Bladder Cancer Clinical Trial

Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment.

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Full Description

OBJECTIVES: I. Evaluate the antineoplastic activity of piritrexim and its effect on the survival of patients with advanced urothelial carcinoma previously treated with systemic cytotoxic chemotherapy. II. Evaluate the toxicity of piritrexim in these patients.

OUTLINE: Patients receive piritrexim by mouth 3 times daily, 5 days a week, for 3 weeks followed by 1 week of rest. Patients with responding or stable disease continue treatment every 4 weeks until unacceptable toxicity or progression intervenes.

PROJECTED ACCRUAL: A maximum of 40 patients will be entered over 5-6 months if at least 1 response is observed in the first 14 evaluable patients.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma, squamous cell, or adenocarcinoma of the renal pelvis, ureter, bladder, or urethra Progressing regional or metastatic disease after one prior systemic or intra- arterial chemotherapy regimen Bidimensionally measurable disease, e. g.: Pulmonary nodules Palpable lymph nodes Cutaneous or subcutaneous nodules Mediastinal tumor or hepatic metastases if clearly measurable on CT No prior radiotherapy to indicator lesion unless documented progression since completion of radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: (within 2 weeks prior to entry) WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: (within 2 weeks prior to entry) Bilirubin no greater than 2.0 mg/dL AST no greater than twice normal Renal: (within 2 weeks prior to entry) Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 40 mL/min Other: No active unresolved infection No concurrent parenteral antibiotics At least 7 days since parenteral antibiotics No history of prior malignancy within 5 years except: Curatively treated nonmelanomatous skin cancer In situ cancer of the cervix Not pregnant or nursing Adequate contraception required of fertile patients Physically and medically able to take oral medications

PRIOR CONCURRENT THERAPY: Biologic therapy: One prior systemic biological response modifier therapy allowed At least 3 weeks since biologic response modifier therapy and recovered Chemotherapy: See Disease Characteristics At least 3 weeks since chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 3 weeks since major surgery and recovered

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT00002914

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 27 Locations for this study

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Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago Illinois, 60611, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 10309, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa Oklahoma, 74136, United States
CCOP - Geisinger Clinical and Medical Center
Danville Pennsylvania, 17822, United States
Veterans Affairs Medical Center - Nashville
Nashville Tennessee, 37212, United States
Vanderbilt Cancer Center
Nashville Tennessee, 37232, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States
Pretoria Academic Hospital
Pretoria , 0001, South Africa

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT00002914

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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