Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
- Conditions
- Ciliary Body and Choroid Melanoma, Medium/Large SizeExtraocular Extension MelanomaIris MelanomaRecurrent Intraocular MelanomaRecurrent MelanomaStage IV Melanoma
- Interventions
- Registration Number
- NCT00288041
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (bortezomib, paclitaxel, carboplatin) bortezomib 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. Treatment (bortezomib, paclitaxel, carboplatin) 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. Treatment (bortezomib, paclitaxel, carboplatin) paclitaxel 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.
- Primary Outcome Measures
Name Time Method 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 Assessed up to 3 years 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 Assessed up to 3 years 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.
- Secondary Outcome Measures
Name Time Method Time to disease progression From registration to documentation of disease progression, assessed up to 3 years Estimated using the Kaplan-Meier method.
Duration of response 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 Estimated using the Kaplan-Meier method.
Survival time From registration to death due to any cause, assessed up to 3 years Estimated using the Kaplan-Meier method.
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States