A Phase II Study of Bevacizumab in Combination With Vinorelbine in Stage IV Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- vinorelbine tartrate
- Conditions
- Male Breast Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Response rate to combination therapy with bevacizumab and vinorelbine, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells
Detailed Description
OBJECTIVES: I. Determine the complete and partial response rates in patients with stage IV breast cancer treated with concurrent bevacizumab and vinorelbine. II. Determine the side effects of this regimen in these patients. III. Determine the time to disease progression in patients treated with this regimen. IV. Determine the time on study (a reflection of time to progression, treatment-related side effects, and patient preference) of patients treated with this regimen. V. Assess urine protein/creatinine ratio and serum complement levels as screening measures for renal injury in patients treated with bevacizumab. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above. PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed stage IV breast cancer
- •Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
- •Must meet 1 of the following criteria:
- •Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
- •Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
- •At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •No CNS metastases by CT scan or MRI within the past 6 weeks
- •No prior or concurrent primary CNS tumor on physical exam
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (bevacizumab, vinorelbine tartrate)
Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.
Intervention: vinorelbine tartrate
Treatment (bevacizumab, vinorelbine tartrate)
Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.
Intervention: bevacizumab
Treatment (bevacizumab, vinorelbine tartrate)
Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Response rate to combination therapy with bevacizumab and vinorelbine, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame: Up to 6 years
Secondary Outcomes
- Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0(Up to 6 years)
- Time to progression(Time from the first treatment on study until the time of documented disease progression, assessed up to 6 years)