Phase II Trial of Carboplatin, Weekly Paclitaxel and Biweekly Bevacizumab in Patients With Unresectable Stage IV Melanoma
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
II. Determine the toxicity profile of this regimen in these patients.
Secondary I. Determine the distribution of overall survival times in patients treated with
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Constructed using the properties of the binomial distribution. Estimated using the Kaplan-Meier method.
Time from registration to documentation of disease progression, assessed up to 8 weeks
North Central Cancer Treatment Group
United States: Food and Drug Administration
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