Phase II Trial of Carboplatin, Weekly Paclitaxel and Biweekly Bevacizumab in Patients With Unresectable Stage IV Melanoma
Overview
- Phase
- Phase 2
- Intervention
- carboplatin
- Conditions
- Recurrent Melanoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.
Detailed Description
OBJECTIVES: Primary I. Determine the anti-tumor activity of carboplatin, paclitaxel, and bevacizumab, in terms of progression-free survival, in patients with unresectable stage IV melanoma. II. Determine the toxicity profile of this regimen in these patients. Secondary I. Determine the distribution of overall survival times in patients treated with this regimen. II. Determine the response rate in patients treated with this regimen. III. Determine the changes in blood levels of vascular endothelial growth factor in patients treated with this regimen. IV. Determine the changes in immune homeostasis in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed melanoma
- •Unresectable stage IV disease
- •Evidence of metastatic disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No radiologically confirmed invasion of adjacent organs (e.g., duodenum or stomach)
- •No tumor invasion of major blood vessels
- •No history of primary brain tumor or other CNS disease
- •No brain metastases by MRI or CT scan
- •Performance status - ECOG 0-2
- •More than 4 months
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (carboplatin, paclitaxel, bevacizumab)
Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: carboplatin
Treatment (carboplatin, paclitaxel, bevacizumab)
Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: paclitaxel
Treatment (carboplatin, paclitaxel, bevacizumab)
Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: bevacizumab
Treatment (carboplatin, paclitaxel, bevacizumab)
Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Progression free survival
Time Frame: Time from registration to documentation of disease progression, assessed up to 8 weeks
Constructed using the properties of the binomial distribution. Estimated using the Kaplan-Meier method.
Secondary Outcomes
- Confirmed tumor response (complete response or partial response)(Up to 5 years)
- Clinical response rate(Up to 5 years)
- Overall survival(Time is defined as the time from registration to death due to any cause, assessed up to 5 years)