Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size
Extraocular Extension Melanoma
Recurrent Intraocular Melanoma
Stage IV Melanoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma|
- 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 [ Time Frame: Assessed up to 3 years ] [ Designated as safety issue: No ]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.
- Adverse event profile as measured by NCI-CAE version 3.0 [ Time Frame: Assessed up to 3 years ] [ Designated as safety issue: Yes ]The maximum grade for each type of toxicity will be recorded for each patient at each evaluation. The frequency and severity of each type of toxicity will be determined overall and by course.
- Time to disease progression [ Time Frame: From registration to documentation of disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method.
- Duration of response [ Time Frame: From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method.
- Survival time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method.
|Study Start Date:||October 2005|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (bortezomib, paclitaxel, carboplatin)
Patients will receive an infusion of bortezomib twice in week 1 and once in week 2. They will also receive a 3-hour infusion of paclitaxel and an infusion of carboplatin once in week 1. Treatment may repeat every 3 weeks for as long as benefit is shown.
Other Names:Drug: paclitaxel
Other Names:Drug: bortezomib
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288041
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Gary Croghan||Mayo Clinic|