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Phase III 6 vs 12 Tx Adjuvant FOLFOX + Celecoxib or Placebo in Resected Stage III Colon Cancer
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PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ben Priestley, 650-723-2990 (Palo Alto and South Bay locations).
Stanford Investigators
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Phase I/II Ipilimumab + Radiation in Melanoma, Non-Hodgkin Lymphoma and Colorectal Carcinoma
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This pilot phase 1-2 trial studies the side effects and best of dose ipilimumab when given together with local radiation therapy and to see how well it works in treating patients with recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer.
* The phase 1 component ("safety") of this study is ipilimumab 25 mg monotherapy.
* The phase 2 component ("treatment-escalation") of this study is ipilimumab 25 mg plus radiation combination therapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Erin Waller, 650-725-0379.
Lead Sponsor
Stanford Investigators
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Phase III Chemotherapy +/-Atezolizumab as Adjuvant Tx in Colon Cancer &Deficient DNA Mismatch Repair
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This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Sigurdis Haraldsdottir, 650-498-7061.
Stanford Investigators
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Phase Ib/II Hu5F9-G4 in Combination w/ Cetuximab in Solid Tumors & Advanced Colorectal Cancer
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The primary objectives of this study are: (Phase 1b) to investigate the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) for magrolimab in combination with cetuximab; and (Phase 2) to evaluate overall response rate (ORR) of magrolimab in combination with cetuximab in participants with Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) mutant and KRAS wild-type colorectal cancer (CRC).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase Ib Atezolizumab (Anti-PD-L1 Antibody) +/- Bevacizumab and/or Other Treatments in Solid Tumors
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This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants with solid tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Telotristat Etiprate in Carcinoid Syndrome Not Controlled by Somatostatin Analog Therapy
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The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Hemamalini Vairamuthu, 650-723-0186.
Stanford Investigators
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Phase III Chemo + ChemoXRT +/- HyperAcute-Pancreatic CA Vaccine in Surgically Resected Pancreatic CA
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The purpose of this study is to assess overall survival after treatment with a regimen of adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical resection.
Stanford is currently not accepting patients for this trial.
For more information, please contact Donna Williams, 6504986608.
Stanford Investigators
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Phase 1b Urelumab + Cetuximab in Advanced / Metastatic CRC or SCCHN
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The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Stanford is currently not accepting patients for this trial.
For more information, please contact Risa Jiron, 650-736-1598.
Stanford Investigators
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Phase II Pazopanib vs. Placebo in Progressive Carcinoid Tumors
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This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ben Priestley, 650-723-2990.
Stanford Investigators
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Phase II GVAX Pancreas Vaccine +Cyclophosphamide +CRS-207 +/-Nivolumab in Pancreatic Adenocarcinoma
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The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).
Stanford is currently not accepting patients for this trial.
For more information, please contact Melissa Worman, 650-725-0379.
Stanford Investigators
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Phase III Brivanib vs Placebo as Adjuvant Therapy to TACE in Unresectable Hepatocellular Carcinoma
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The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Rebecca Bristol, 6507213114.
Stanford Investigators
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Phase III Vitamin D3 Supplementation in Previously Untreated Metastatic Colorectal Cancer (SOLARIS)
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This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).
Stanford is currently not accepting patients for this trial.
For more information, please contact Site Public Contact, 650-498-7061.
Stanford Investigators
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Phase II Irinotecan +Cetuximab +/-Anti-AngiogenicAntibody Ramucirumab in K-rasWildtype Colorectal Ca
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RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Telotristat Etiprate (LX1606) Long-term Extension Study
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The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
Stanford is currently not accepting patients for this trial.
For more information, please contact Jennifer Dauriac, 650-736-0697.
Stanford Investigators
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Phase II Pembrolizumab in Locally Advanced Unresectable or Metastatic MMR Deficient or MSI High CRC
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In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy.
There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody.
The primary hypothesis is that Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor in participants with locally advanced unresectable or metastatic MMR deficient or MSI high CRC is greater than 15%.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I/II Indoximod + Gemcitabine & Nab-Paclitaxel in Metastatic Adenocarcinoma of the Pancreas
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This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melissa Worman, 650-725-0379.
Stanford Investigators
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Phase III 177Lu-DOTA0-Tyr3-Octreotate vs Octreotide LAR in Inoperable Midgut Carcinoid Tumours
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This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Flordeliza Mendoza, 650-724-2056.
Stanford Investigators
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Phase II Gemcitabine & Paclitaxel vs 5-Fluorouracil Leucovorin & Irinotecan in Pancreatic Cancer
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This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Nilotinib vs Imatinib for Unresectable or Metastatic GIST
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This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Stanford is currently not accepting patients for this trial.
For more information, please contact Heidi Kaiser, 6507240079.
Stanford Investigators
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Phase I Oral mTOR Inhibitor RAD001 in Combo w/ Capecitabine for Metastatic Breast
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In order to improve the survival of metastatic breast patients, it is important to investigate the use of novel therapeutic agents combined with known active agents in the treatment of breast cancer. This is a phase I study evaluating the maximum tolerated doses and toxicities of RAD001 in combination with capecitabine for the treatment of metastatic breast cancer. RAD001 (INN: everolimus) is a novel macrolide, which is being developed as an antiproliferative drug with applications as an immunosuppressant and anticancer agent. Phase I trials in patients with solid tumors have shown that treatment with RAD001 is well-tolerated with a minimal side effect profile. Capecitabine (Xeloda, Roche) is an oral fluoropyrimidine that was approved in 1998 for the treatment of patients with metastatic breast cancer. The all-oral regimen of RAD001 with capecitabine is an attractive approach as the treatment of metastatic breast cancer has not yet proven to be curative. We also want to find out what possible benefit this combination of drugs might have on treating your cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Lead Sponsor
Stanford Investigators
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Phase I XmAb®18087 in Advanced Neuroendocrine and Gastrointestinal Stromal Tumors
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This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST.
The study will enroll dosing cohorts to establish a MTD/RD and regimen in subjects with advanced NET or GIST, then enroll additional subjects into separate NET and GIST expansion cohorts to collect additional data on safety and potential efficacy of XmAb18087.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase IB HGS1036 in Combination With Chemotherapy in Advanced Solid Malignancies
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The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel.
Stanford Investigators
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Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer
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This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
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Phase II Gemcitabine, Paclitaxel and Bevacizumab Combination as 1st Line Tx for Metastatic Breast CA
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Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
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Phase I MVA-BN?-HER2 Vaccine in HER-2+ Breast CA Following Adjuvant Therapy
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The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast cancer.
The intent of vaccination is to induce a combined antibody and T-cell anti-HER-2 immune response, which is intended to target HER-2-expressing tumor cells, and may induce tumor regression or slow progression of disease.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
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Phase I Atezolizumab (MPDL3280A) IV - Single Agent in Locally Advanced or Metastatic Solid Tumors
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This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Pitsiouni, 650-721-6977.
Stanford Investigators
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Phase III Telotristat Etiprate (LX1606) in Carcinoid Syndrome
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The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.
Stanford is currently not accepting patients for this trial.
For more information, please contact Jennifer Dauriac, 650-736-0697.
Stanford Investigators
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Phase III Pembrolizumab vs Chemotherapy in MSI-H / dMMR Stage IV Colorectal Carcinoma
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In this study, participants with stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal carcinoma (CRC) will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer
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The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.
Stanford is currently not accepting patients for this trial.
For more information, please contact Heidi Kaiser, 6507240079.
Stanford Investigators
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Phase II Epacadostat + Pembrolizumab in Metastatic Gastroesophageal Junction &Gastric Adenocarcinoma
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This phase 2 trial evaluates the benefit of epacadostat plus pembrolizumab in combination to treat patients with gastroesophageal junction or gastric cancer that has spread to other parts of the body and cannot be removed by surgery. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving epacadostat and pembrolizumab may work better in treating patients with gastroesophageal junction or gastric cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ativ L. Zomet, 650-736-0697.
Stanford Investigators
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Phase 1a/1b RO7198457 in Combination w/ Atezolizumab in Locally Advanced or Metastatic Tumors
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This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II EZN-2208 (PEG-SN38) Administered +/- Cetuximab in Metastatic Colorectal Carcinoma (mCRC)
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This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy, safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be randomized to EZN-2208 + cetuximab or to standard of care (Camptosar® + cetuximab), patients must have failed regimens containing irinotecan (Camptosar®, CPT-11), oxaliplatin (Eloxatin®), and fluoropyrimidine.
After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Pitsiouni, 6507213114.
Stanford Investigators
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Phase I RO6958688 in Locally Advanced and/or Metastatic CEA(+) Solid Tumors
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Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical study of single-agent RO6958688 in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The study will be conducted in two parts. Part I of the study will investigate the safety and pharmacokinetics of a single dose of RO6958688 in single participant cohorts with dosing starting from a minimal anticipated biological effect level dose of 0.05 milligrams (mg) and up to a maximum dose of 2.5 mg. Part II will establish the appropriate therapeutic dose based on safety, pharmacokinetics, and the maximum tolerated dose (MTD) of RO6958688 for the once per week (QW) regimen, every three weeks (Q3W) regimen, and for the step up dosing regimen.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II RRx-001 vs Regorafenib in Metastatic Colorectal Cancer
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This two-stage study is designed to compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies in a parallel comparative study.
Patients who are suffering from advanced or metastatic (meaning the disease has spread) colorectal cancer are invited to participate in this study. There will be two groups of patients (Randomized, open label study), one of these will receive RRx-001 and the other one will receive regorafenib. If patients qualify to participate in this study, they will be randomly assigned to the 'interventional arm' where patients will receive the experimental drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care, Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance (1 out of 3) of receiving regorafenib.
On progression in the first part of the study, provided ECOG performance status is adequate, and if clinically appropriate i.e. there are no absolute or relative contraindications in the opinion of the Investigator, all subjects will enter the second part of the study and receive irinotecan plus bevacizumab.
Whether patients are given RRx-001 or regorafenib, they will also receive best supportive care, which includes treatments to help manage side effects and symptoms of cancer. This is an open label study, which means patients will know to which of these treatments, RRx-001 or regorafenib, they are assigned.
Stanford is currently not accepting patients for this trial.
For more information, please contact Rachel Kasson, 650-723-0168.
Stanford Investigators
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Phase IB RO6958688 + Atezolizumab in Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
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This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of RO6958688 in combination with atezolizumab. Part I of the study is subdivided into parts IA and IB. Part IA is dose escalation with a starting dose of 5 mg of RO6958688 given QW (once a week) and a fixed, flat dose of 1200 mg given Q3W (every 3 weeks) of atezolizumab, to evaluate the safety and determine the MTD of RO6958688 in combination with atezolizumab. Part IB is a dose/schedule finding part that will explore different administration schedules of RO6958688 in combination with atezolizumab (1200 mg Q3W) to establish the appropriate dose/schedule of RO6958688 in combination with atezolizumab.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II/III Chemo +/- Radiation Therapy in Locally Advanced Rectal Cancer Undergoing Surgery
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The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ben Priestley, 650-723-2990.
Stanford Investigators
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Phase I Safety Tolerability Pharmacokinetics&Antitumor Activity of PEEL-224 in Advanced Solid Tumors
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This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of PEEL-224 in patients with advanced solid tumors.
Stanford Investigators
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Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors
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Given the lack of other viable treatment options for metastatic neuroendocrine tumors, contrasted with our positive anecdotal experience, and the relative tolerability of the treatment regimen for colorectal cancer patients, we propose a single-institution phase II trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Heidi Kaiser, 6507240079.
Stanford Investigators
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Phase II GS-6624 + FOLFIRI in Metastatic KRAS Mutant Colorectal Adenocarcinoma
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The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.
Stanford is currently not accepting patients for this trial.
For more information, please contact Heidi Kaiser, 6507240079.
Stanford Investigators
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Phase II GS-6624 + Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
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This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.
Stanford is currently not accepting patients for this trial.
For more information, please contact Donna Collins Williams, 6504986608.
Stanford Investigators
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Phase I Personalized LiveAttenuated DoubleDeleted ListeriaMonocytogenes ImmunoTx in ColorectalCancer
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This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Flordeliza Mendoza, CCRC, 650-724-2056.
Stanford Investigators
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Long Term Follow Up in Previously Treated Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy
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This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase Ib Atezolizumab + Cobimetinib in Locally Advanced or Metastatic Solid Tumors
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This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lisa Zhou, 650-736-4112.
Stanford Investigators
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Phase I FG-3019, Gemcitabine and Erlotinib for Locally Advanced or Metastatic Pancreatic Cancer
Not Recruiting
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Objectives
* Primary: To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
* Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with gemcitabine and erlotinib
Stanford is currently not accepting patients for this trial.
For more information, please contact Donna Williams, 6504986608.
Stanford Investigators
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Phase Ib/III Bemarituzumab +ChemoTx & Nivolumab vs ChemoTx & Nivolumab Alone in Gastric & GEJ Cancer
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The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.
The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
Stanford Investigators
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Phase II Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
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This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Stanford is currently not accepting patients for this trial.
For more information, please contact Site Public Contact, 650-498-7061.
Stanford Investigators
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Collection of Biospecimen & Clinical Information in Patients w/ Gastrointestinal Cancers
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We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal cancers.
PRIMARY OBJECTIVES:
1. To collect and store tumor and normal tissue (previously collected paraffin embedded or frozen specimen) and blood in patients with gastrointestinal (GI) cancers.
SECONDARY OBJECTIVES:
1. Collect detailed clinical information via a patient questionnaire that includes demographic, socioeconomic, lifestyle, family, past medical, medication and cancer histories
2. Collect details about the tumor specimen extracted from patient charts.
Lead Sponsor
Stanford Investigators
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Phase Ib Cibisatamab +/-Atezolizumab After Pretreatment w/ Obinutuzumab in Colorectal Adenocarcinoma
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CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase lll Xilonix for Improving Survival in Metastatic Colorectal Cancer
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The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Flordeliza Mendoza, 650-724-2056.
Stanford Investigators
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Phase I/II BTK Inhibitor Ibrutinib in Combo with Durvalumab in Relapsed or Refractory Solid Tumors
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This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I Paclitaxel for Nano-dispersion (PICN) +/- Carboplatin in Advanced Solid Malignancies
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Phase I study of SPARC1023 alone and in combination with carboplatin
Stanford is currently not accepting patients for this trial.
For more information, please contact Flordeliza Mendoza, 650-724-2056.
Stanford Investigators
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Phase III Somatuline Depot Injection in the Treatment of Carcinoid Syndrome
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The purpose of this study was to determine whether monthly deep subcutaneous (s.c.) injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue medication to control symptoms in subjects with carcinoid syndrome.
Stanford is currently not accepting patients for this trial.
For more information, please contact Heidi Kaiser, 6507240079.
Stanford Investigators
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CGT4859 for the Treatment of FGFR2/3-Altered Solid Tumors
Recruiting
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This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.
Stanford Investigators
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Expanded Access 177Lu-DOTA0-Tyr3-Octreotate in Somatostatin Receptor(+) / Midgut Carcinoid Tumors
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Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Lanreotide+BSC vs Placebo+BSC for Tumor Cntl in Typical/Atypical Lung NeuroendocrineTumors
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This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs.
This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period.
The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours.
Recent updates of National Cancer Institute Cancer Network (NCCN) \& European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5.
The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma
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A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma
Stanford is currently not accepting patients for this trial.
For more information, please contact Donna Collins Williams, 6504986608.
Stanford Investigators
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Phase xx ImmunOtherapy Combinations w/Chemotherapy in UnTreated MetastatIc Pancreatic AdenOcarciNoma
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This trial is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of first-line chemo-immunotherapy combinations in participants with metastatic pancreatic ductal adenocarcinoma (mPDAC).
Stanford is currently not accepting patients for this trial.
For more information, please contact Gino Pineda, 650-725-8474.
Stanford Investigators
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Phase III: 5-FU/ Leucovorin/Oxaliplatin (mFOLFOX6) +/- Bevacizumab in Stage II & III Colon Carcinoma
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This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy together with bevacizumab may kill more tumor cells. It is not yet known whether treatment with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 650-724-1953.
Stanford Investigators
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Phase I/Ib Targeted Therapies in Subpopulations with Metastatic Colorectal Cancer (INTRINSIC)
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This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Stanford is currently not accepting patients for this trial.
For more information, please contact gitrialeligibility@stanford.edu, gitrialeligibility@stanford.edu.
Stanford Investigators
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Phase II Magrolimab +/- Bevacizumab & FOLFIRI in Previously Treated Advanced Inoperable mCRC
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The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).
The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer
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The purpose of the research is to evaluate whether both chemotherapy and radiotherapy can lead to higher rates of clinical complete response leading to organ preservation in human subjects with cancer. The objective is to learn if this treatment approach may safely be used as an alternative to the standard treatment for rectal cancer and to know the quality-of-life in these patients.
Stanford is currently not accepting patients for this trial.
For more information, please contact Eleanor Brown, 650-724-4606.
Lead Sponsor
Stanford Investigators
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Phase III ADI-PEG 20 + BSC vs Placebo + BSC in Advanced HCC with Prior Systemic Tx Failure
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This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with hepatocellular carcinoma who have failed prior systemic treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the hepatocellular carcinoma cells will starve and die.
Stanford is currently not accepting patients for this trial.
For more information, please contact Flordeliza Mendoza, 650-724-2056.
Stanford Investigators
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Phase 2 Study of MK-3475 in Microsatellite Unstable (MSI) Tumors
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This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T cells) is effective (anti-tumor activity) and safe in three different patient populations. These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative colon cancer and 3. patients with other MSI positive cancers.
Stanford is currently not accepting patients for this trial.
For more information, please contact Donna Williams, 650-498-6608.
Stanford Investigators
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Phase 1 SNX-5422 and Everolimus in Neuroendocrine Tumors or Renal Cell Carcinoma
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Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in combination with everolimus.
Stanford is currently not accepting patients for this trial.
For more information, please contact Jennifer Dauriac, 650-736-0697.
Stanford Investigators
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A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors
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In this study, patients with advanced solid tumors will undergo \[18F\]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.
Stanford Investigators
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Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer
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To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer
Stanford is currently not accepting patients for this trial.
For more information, please contact Jenna Rogers, 6507234467.
Stanford Investigators
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Phase II MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)
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This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth.
Stanford is currently not accepting patients for this trial.
For more information, please contact George A. Fisher, 650-498-7061.
Stanford Investigators
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Cetuximab in Combination w/ Oxaliplatin, Capecitabine, & XRT Followed by Surgery for Rectal Cancer
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The objectives of this study are to:
1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
2. To determine the maximum-tolerated dose (MTD) when capecitabine
* oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)
Stanford is currently not accepting patients for this trial.
For more information, please contact Heidi Kaiser, 6507240079.
Stanford Investigators
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Phase II Temozolomide or Temozolomide plus Capecitabine in Advanced Pancreatic NETs
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This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Benjamin Priestley, 650-723-2990.
Stanford Investigators
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Phase Ib/II APX005M+Gemcitabine &nab-Paclitaxel +/-Nivolumab in Metastatic Pancreatic Adenocarcinoma
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The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.
Stanford is currently not accepting patients for this trial.
For more information, please contact Stanford Cancer Clinical Trials Office, Outreach, 650-498-7061.
Stanford Investigators
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Clincal and Pathologic Studies of Patients Undergoing Treatment with EGFR Inhibitors
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Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factor receptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung, and head and neck. Blockade of the EGFR results in inhibition of multiple downstream pathways, leading to slowed tumor growth. In addition, these inhibitors may enhance anti-tumor immune responses through uncharacterized mechanisms. While producing significant responses in many settings, EGFR inhibitors also result in significant skin toxicity (rash) in a high percentage of patients. Multiple studies have correlated the presence and severity of rash with clinical response. Unfortunately, severe rash can often lead to dose delays, reductions, or even discontinuation of EGFR inhibitors, thus limiting their efficacy. The mechanism of both the rash and its correlation with tumor response is poorly understood. Skin biopsies display a robust leukocyte infiltrate, but a systematic analysis of the type of infiltrating leukocytes, activation state, or homing receptor expression has not been performed. Chemokines and chemokine receptors control leukocyte trafficking to the skin and other tissue sites, and defined receptor profiles for skin-, gut-, and lung-homing leukocytes are well established. In this study, the investigators propose to evaluate the homing phenotype of leukocytes from peripheral blood and skin biopsies of patients receiving EGFR inhibitors. The investigators will use RNA microarrays to evaluate the expression of chemokines and other key genes regulated in skin during treatment. The investigators will utilize in vitro methods to investigate effects of EGFR inhibitors on imprinting of T cell tissue-specific homing receptors. The investigators will examine correlations among the pathologic data, clinical findings, and tumor response. If validated, peripheral blood evaluation could potentially be used as a predictive indicator for patients receiving EGFR inhibitors. This study may also identify novel targets for limiting skin toxicity while receiving EGFR inhibitors, thus allowing maximal dosing and clinical response from these agents.
Stanford is currently not accepting patients for this trial.
For more information, please contact Russell Pachynski, 6509066530.
Lead Sponsor
Stanford Investigators
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