Stage IV Melanoma Clinical Trial
Official title:
A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with metastatic melanoma. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may help paclitaxel and carboplatin kill more tumor cells by making tumor cells more sensitive to these drugs
PRIMARY OBJECTIVE:
I. Determine the confirmed tumor response rate and adverse event profile of bortezomib,
carboplatin, and paclitaxel as first-line therapy for patients with metastatic melanoma.
SECONDARY OBJECTIVE:
I. Evaluate time to tumor progression, overall survival, and duration of response.
OUTLINE: This is a multicenter study.
Patients receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, and 8 and
paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Treatment repeats
every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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