PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM

Inclusion 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