Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Efficacy []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically proven unresectable or metastatic urothelial cancer
-
No transitional cell histologies
-
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Hematopoietic:
-
WBC at least 3,500/mm^3
-
Platelet count greater than 150,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
Renal:
-
Creatinine less than 1.5 mg/dL OR
-
Creatinine clearance greater than 55 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- No other concurrent malignancy except basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Study Chair: Dean F. Bajorin, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 95-031
- CDR0000064373
- NCI-V95-0743