NCT00002684

Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Bladder Cancer
• Urethral Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	ifosfamide
DRUG	paclitaxel

Timeline

• Start date: 1995-05-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-07-03

Locations

1 site across 1 country: United States