Heather Wakelee
A Phase 1/2 Study of Aflibercept Administered in Combination with Pemetrexed and Cisplatin in Patients with Advanced Carcinoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Phase 1: To determine the dose-limiting toxicities (DLT) and recommended dose (RD) of aflibercept administered intravenously (IV) every 3 weeks in combination with pemetrexed and cisplatin Phase 2: To evaluate the Objective Response Rate (ORR) and Progression-free Survival (PFS) associated with treatment at the RD in patients with previously untreated non-small cell lung cancer (NSCLC)
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Afibercept
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Histological confirmation of cancer:
Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
2. Resolution of toxicity from prior therapy (except alopecia) to Grade <=1
3. Measurable disease per modified RECIST Criteria (Phase 2 only)
4. Age >= 18 years
5. ECOG performance status 0-1
6. Hemoglobin >=9.0 g/dL
7. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
8. Platelet count >=100 x 10^9/L
9. INR <=1.5 x ULN
10. PTT <=1.5 x ULN
11. Normal serum creatinine
13. Calculated creatinine clearance >60 mL/min
14. ALT <= 2.5 x ULN (if liver metastases <= 5 x ULN)
15. AST <= 2.5 x ULN (if liver metastases <= x ULN)
16. Total bilirubin < =1.5 x ULN (if liver metastases <=3 x ULN)
17. Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
18. For patients of childbearing potential, willingness to utilize adequate contraception
19. Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
20. Institutional Review Board (IRB) approved, signed and dated informed consent form
Key Exclusion Criteria:
1. Prior treatment with aflibercept, pemetrexed, or cisplatin
2. Untreated, symptomatic or progressive brain metastases, spinal cord compression, or carcinomatous meningitis or other clinical evidence of CNS involvement. Patients with treated brain metastases must have been asymptomatic for at least 3 months
3. Use of NSAIDS and other potentially nephrotoxic drugs (e.g. aminoglycoside antibiotics) <= 1 week prior to the initial administration of aflibercept
4. Surgery <= 4 weeks prior to the initial administration of aflibercept and/ or incomplete wound healing
5. Anti-VEGF therapy <= 4 weeks prior to the initial administration of aflibercept
6. Chemotherapy <= 4 weeks prior to the initial administration of the aflibercept
7. Other investigational treatment <= 4 weeks prior to the initial administration of aflibercept
8. Radiation (curative or palliative) to >30% of the bone marrow reserve or <= 4 weeks prior to the initial administration of aflibercept
9. Systolic pressure >150 mm Hg on at least 2 separate days <= 1 week prior to the initial administration of aflibercept
10. Diastolic pressure >100 mm Hg on at least 2 separate days <= 1 week prior to the initial administration of aflibercept
11. Any of the following <=6 months prior to the initial administration of aflibercept:
- Myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, or congestive heart failure requiring hospitalization
- Cerebrovascular accident or transient ischemic attack, or Grade >= 2 peripheral neuropathy
- Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
- Deep vein thrombosis, pulmonary embolism, or other thromboembolic event
- Grade 3 or 4 hemorrhagic event
12. Breast-feeding or pregnancy
13. Known human immunodeficiency virus (HIV) infection
14. Known active hepatitis B or C
15. Bleeding diathesis or evidence of active bleeding
16. Any acute or chronic medical or psychiatric condition or laboratory abnormality that, in the judgment of the investigator, makes the patient inappropriate for entry into this study
Additional Study Details
Official Title:
Phase I/II Aflibercept in Combo with Pemetrexed and Cisplatin in Patients with Advanced CarcinomaAnticipated start date:
10/16/2008Lead Sponsor:
Regeneron PharmaceuticalsInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Phase 1: To determine the dose-limiting toxicities (DLT) and recommended dose (RD) of aflibercept administered intravenously (IV) every 3 weeks in combination with pemetrexed and cisplatin
- Phase 2: To evaluate the Objective Response Rate (ORR) and Progression-free Survival (PFS) associated with treatment at the RD in patients with previously untreated non-small cell lung cancer (NSCLC)
Secondary Outcomes:
- Characterize the safety profile of the combination
- Characterize the pharmacokinetics (PK) of aflibercept and pemetrexed
- Evaluate the immunogenicity of aflibercept
- Identify potential biomarkers of aflibercept activity
Total Number to be Enrolled:
100Total Number to be Enrolled at Stanford:
27More Information
Secondary ID(s):
- LUN0028
- NCT00794417
- VGFT-ST-0708
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/5/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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