A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
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.
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed tumor response rate defined as the total number of evaluable patients whose objective tumor status is either a complete or partial response according to the RECIST criteria
If at most 3 of the first 19 eligible patients enrolled achieved a partial or complete response by the RECIST criteria, then enrollment would be terminated and the regimen would be considered inactive in this patient population. A 90% confidence interval will be constructed using the Duffy-Santer approach.
Assessed up to 3 years
United States: Food and Drug Administration
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