Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
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|ClinicalTrials.gov Identifier: NCT00002684|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Urethral Cancer||Drug: cisplatin Drug: ifosfamide Drug: paclitaxel||Phase 2|
- Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies).
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors|
|Study Start Date :||May 1995|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
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): NCT00002684
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Dean F. Bajorin, MD||Memorial Sloan Kettering Cancer Center|