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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Progression free survival
Constructed using the properties of the binomial distribution. Estimated using the Kaplan-Meier method.
Time frame: Time from registration to documentation of disease progression, assessed up to 8 weeks
Confirmed tumor response (complete response or partial response)
A ninety percent confidence interval for the true proportion of confirmed tumor responses will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution.
Time frame: Up to 5 years
Clinical response rate
A ninety percent confidence interval for the true clinical response rate will be calculated.
Time frame: Up to 5 years
Overall survival
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: Time is defined as the time from registration to death due to any cause, assessed up to 5 years
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