Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer|
- Proportion of patients with clinical response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||September 2004|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin.
- 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.
Show 35 Study Locations
|Study Chair:||David F. McDermott, MD||Beth Israel Deaconess Medical Center|
|Study Chair:||Michael B. Atkins, MD||Beth Israel Deaconess Medical Center|