Ellie (Alice) Guardino
Phase II Gemzar, Taxol & Avastin Combination as 1st Line Tx for Metastatic Breast CA
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Gemcitabine
- Drug: Paclitaxel
- Drug: Bevacizumab
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Patients must have previously untreated metastatic breast cancer.
- Patients may have had prior chest wall irradiation or palliative radiation to bony sites for control of pain or fracture. These sites of disease, however, will not be considered as sites of measurable disease.
- Use of bisphosphonates will be permitted.
- Patients must have an ECoG performance status of 0 or 1.
- Patients must have adequate hepatic, renal and bone marrow function as defined by the following:
o granulocyte count >= 1500/mm^3
o platelet count >= 100,000/mm^3
o hemoglobin >=8.0 g/dl.
o SGoT/SGPT <= 2.5X the institutional upper limit of normal (ULN) if alkaline phosphatase is d ULN or alkaline phosphatase may be up to 4X ULN if transaminases are d ULN.
o total bilirubin within institutional limits of normal.
o calculated creatinine clearance >= 30 ml/min using the formula:
a. Ccr(ml/min) = ((140-age in years) X (wt in kg) X 0.85 (females))/(72 X Serum creatinine in mg/dl)
- All patients must be >= 18 years of age.
- Patients with prior anthracyclines in the adjuvant setting or prior chest wall radiation must have left ventricular ejection fraction (LVEF) within the institutional range of normal as assessed by pretreatment MUGA scan or ECHo.
- All patients must give signed written informed consent.
o Patients may have received adjuvant therapy as long as therapy complete >12 months from study entry.
Key Exclusion Criteria:
- Patients on hormonal therapy
- Patients had prior treatment for metastatic disease with cytotoxic agents or inhibitors of EGFR.
- Her2NEU positive breast cancers, either IHC 3+ or FISH +.
- Patients who are pregnant/lactating. Patients of childbearing potential must have a negative pregnancy test taken <= 2 weeks prior to study enrollment. Patients of childbearing potential must consent to the use of effective contraception during the study period and for six months thereafter.
- Patients have had active malignancies other than breast cancer in the past 5 years with the exception of in situ carcinoma of the cervix or nonmelanomatous skin cancer.
- Patients have active or unresolved infection.
- Patients with pre-existing peripheral neuropathy > Grade 1.
- Patients with a prior history of severe hypersensitivity reaction to paclitaxel, gemcitabine, bevacizumab or drugs formulated with polysorbate 80.
- Patients ineligible due to Bevacizumab-specific concerns:
o Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
o Blood pressure of >150/100 mmHg
o Unstable angina
o New York Heart Association (NYHA) Grade II or greater congestive heart failure
o History of myocardial infarction within 6 months
o History of stroke within 6 months
o Clinically significant peripheral vascular disease
o Evidence of bleeding diathesis or coagulopathy
o Presence of central nervous system or brain metastases
o Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
o Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
o Urine protein:creatinine ratio >= 1.0 at screening
o History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
o Serious, non-healing wound, ulcer, or bone fracture
o Inability to comply with study and/or follow-up procedures
Additional Study Details
Official Title:
Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast CancerAnticipated start date:
2/1/2006Lead Sponsor:
Stanford UniversityCollaborator(s):
- Genentech
- Eli Lilly
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- Time to progression will be the primary outcome measure for this trial.
Secondary Outcomes:
- Overall survival and response rates will be secondary outcome measures.
- In addition, toxicity data will be collected for a comprehensive safety analysis of this regimen in this patient population.
Total Number to be Enrolled:
50Total Number to be Enrolled at Stanford:
50More Information
Secondary ID(s):
- 96052
- BRSMTS0007
- NCT00403130
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:
8/25/2009PLEASE 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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