A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
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.
Interventional
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
No
Gary Croghan
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
NCI-2009-00138
NCT00288041
October 2005
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |