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Home > "B" Clinical Trials Conditions > Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial  Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
For Condition: recurrent breast cancer,stage 4 colon cancer,Stage 4 rectal cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bevacizumab may stop the growth of breast cancer by stopping blood flow to the tumor. PURPOSE: Clinical trial to study the effectiveness of bevacizumab in treating patients who have previously received bevacizumab for metastatic breast or colorectal cancer.
Details: OBJECTIVES: - Provide an extension of bevacizumab treatment to patients with metastatic breast or colorectal cancer who received this drug in a prior phase II or III Genentech-sponsored clinical trial. - Determine the safety of long-term administration of this drug in these patients. OUTLINE: This is an open-label, multicenter, extension study. Patients receive bevacizumab IV over 30-90 minutes every 2 or 3 weeks according to the original Genentech treatment schedule. Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 4 months for 1 year. PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic breast or colorectal cancer - Must have received bevacizumab on, and completed participation in, 1 of the following Genentech-sponsored phase II or III clinical trials (less than 3 months since last dose): - GENENTECH-AVF2107g* - GENENTECH-AVF2119g* - GENENTECH-AVF2192g* NOTE: *Patients who were randomized to the control arms of these studies are ineligible - No primary brain tumor or brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Not specified Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) - No bleeding diathesis or coagulopathy Hepatic - No compromised hepatic function - INR less than 1.5 (unless approved to receive concurrent full-dose warfarin) - Bilirubin no greater than 2.0 mg/dL (1.6 mg/dL for patients receiving irinotecan) - AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with documented liver metastases) Renal - No compromised renal function - No proteinuria OR - Proteinuria less than 2 g by 24-hour urine collection - Creatinine no greater than 2.0 mg/dL Cardiovascular - No clinically significant cardiovascular disease - No uncontrolled hypertension (blood pressure greater than 160/110 mm Hg on medication) - No prior myocardial infarction - No prior stroke - No unstable angina - No New York Heart Association grade II-IV congestive heart failure - No serious cardiac dysrhythmia requiring medication - No grade II or greater peripheral vascular disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3-6 months after study participation - No significant traumatic injury within the past 28 days - No seizures uncontrolled with standard medical therapy - No history or physical evidence of other CNS disease - No other disease that would preclude study participation - No metabolic dysfunction - No physical examination or clinical laboratory finding that would preclude study participation - No unresolved or irreversible bevacizumab-related ongoing serious adverse event from prior participation in the Genentech-sponsored phase II or III study - No serious, nonhealing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - More than 28 days since prior major surgical procedure or open biopsy - More than 7 days since prior fine needle aspirations or core biopsies - No anticipated need for a major surgical procedure during study therapy Other - More than 4 weeks since prior participation in other experimental drug studies (except Genentech-sponsored bevacizumab cancer studies) - No concurrent participation in another experimental drug study - No concurrent chronic daily aspirin greater than 325 mg/day - No concurrent nonsteroidal anti-inflammatory medications that would inhibit platelet function in order to treat chronic inflammatory diseases - No concurrent full-dose warfarin unless approved by the investigator - No concurrent full-dose heparin - No concurrent thrombolytic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FairoozKabbinavar, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Fairooz Kabbinavar 310-825-5268
Additional Information:
Study ID Numbers: CDR0000316265; GENENTECH-AVF2540g,UCLA-0212064
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066560
Other Stage 4 Rectal Cancer Studies:
1. Bexarotene in Treating Patients With Metastatic Breast Cancer
2. Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
3. Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
4. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
5. Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
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