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.

Condition	Treatment or Intervention	Phase
recurrent urethral cancer transitional cell carcinoma of the bladder recurrent bladder cancer recurrent transitional cell cancer of the renal pelvis and ureter squamous cell carcinoma of the bladder adenocarcinoma of the bladder	Drug: piritrexim	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  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
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  10309-1016,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa,  Oklahoma,  74136,  United States
Pennsylvania
      CCOP - Geisinger Clinical and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Nashville, Nashville,  Tennessee,  37212,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States
      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705,  United States
      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States
South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa

Study chairs or principal investigators

Bruce J. Roth,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000065289; E-3896
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002914
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08