Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	MSKCC-95031 NCI-V95-0743, NCT00002684

Objectives

1. 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:

• 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

Expected Enrollment

A total of 40 patients will be accrued for this study within 2 years.

Outcomes

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 Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Dean Bajorin, MD, Protocol chair		Ph: 646-422-4333; 800-525-2225

Registry Information
Official Title		Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors
Trial Start Date		1995-05-09
Registered in ClinicalTrials.gov		NCT00002684
Date Submitted to PDQ		1995-05-09
Information Last Verified		2005-12-06
NCI Grant/Contract Number		P30-CA08748

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