Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | 18 and over | Other | MSKCC-95031 NCI-V95-0743, NCT00002684 |
Objectives
- Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies).
Entry Criteria
Disease Characteristics:
- Histologically proven unresectable or metastatic urothelial cancer
- No transitional cell histologies
- Bidimensionally measurable disease
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
Patient Characteristics:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Hematopoietic:
- WBC at least 3,500/mm3
- Platelet count greater than 150,000/mm3
Hepatic:
- Bilirubin less than 2.0 mg/dL
Renal:
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- No other concurrent malignancy except basal cell skin cancer
Expected Enrollment
40A total of 40 patients will be accrued for this study within 2 years.
Outcomes
Primary Outcome(s)Efficacy
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.
Trial Lead Organizations
Memorial Sloan-Kettering Cancer Center
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| Dean Bajorin, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors | |
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| Trial Start Date | 1995-05-09 | |
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| Trial Completion Date | 2007-10-09 | |
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| Registered in ClinicalTrials.gov | NCT00002684 | |
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| Date Submitted to PDQ | 1995-05-09 | |
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| Information Last Verified | 2009-12-11 | |
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| NCI Grant/Contract Number | P30-CA08748 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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