Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT00077129|
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : January 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: carboplatin Drug: paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer|
|Study Start Date :||September 2004|
|Primary Completion Date :||August 2006|
- Proportion of patients with clinical response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077129
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|