Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Kidney Cancer
- Sponsor
- Eastern Cooperative Oncology Group
- Enrollment
- 22
- Locations
- 35
- Primary Endpoint
- Proportion of patients with clinical response
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with locally advanced or metastatic collecting duct renal cell cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin. Secondary * Determine the tolerability of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 14-22 patients will be accrued for this study within 4.5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of patients with clinical response
Secondary Outcomes
- Toxicity