S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage IV bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, renal pelvis, ureter, and urethra Stage T2-4, N0-3, M1 OR stage T2-4, N+, M0, unresectable disease The following additional histologic subtypes are eligible: Poorly differentiated TCC Predominant TCC with rare foci of squamous differentiation Predominant TCC with rare foci of adenocarcinoma The following histologic subtypes are ineligible: Adenocarcinoma Small cell carcinoma Sarcoma Squamous cell carcinoma Mixed adeno/squamous/transitional histology Incurable by surgery or radiotherapy Progressed or recurred after 1, and only 1, prior cisplatin- or carboplatin-containing systemic regimen for metastatic disease Measurable disease Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease No uncontrolled central nervous system (CNS) metastases CNS metastases that have responded to or stabilized after prior radiotherapy are allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,200/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin less than 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (SGOT) less than 3 times ULN (5 times ULN if liver metastases are present) Renal Creatinine less than 2 times ULN Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 28 days since prior chemotherapy No prior topoisomerase I inhibitors (e.g., irinotecan or topotecan) Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 28 days since prior radiotherapy to the pelvis Surgery Not specified Other Recovered from prior therapy Prior adjuvant therapy allowed At least 14 days since prior Hypericum perforatum (St. John's Wort) More than 7 days since prior phenytoin, phenobarbital, carbamazepine, or any other enzyme-inducing anticonvulsant drugs (EIACDs) No St. John's Wort during and for 7 days after study participation No concurrent EIACDs No concurrent medications that cause myelosuppression No concurrent medications that cause diarrhea Concurrent gabapentin or other non-EIACDs are allowed
Sites / Locations
Arms of the Study
Arm 1
Experimental
Treatment
Irinotecan