Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Bladder Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the bladder Locally advanced or metastatic disease Unidimensionally measurable disease by physical exam or imaging study The following are not considered measurable disease: Bone only disease Pleural or peritoneal effusions CNS lesions Irradiated lesions unless disease progression was documented after radiotherapy Not amenable to surgery PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 2.0 mg/dL Renal Creatinine ≤ 2.0 mg/dL Gastrointestinal No active inflammatory bowel disease No significant bowel obstruction No chronic diarrhea Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other active malignancy except nonmelanoma skin cancer No mental incapacitation or psychiatric illness that would preclude giving informed consent No other severe disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy No more than 1 prior platinum-based chemotherapy regimen At least 4 weeks since prior chemotherapy No prior irinotecan or gemcitabine No other concurrent chemotherapy Endocrine therapy No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), and intermittent dexamethasone as an antiemetic Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery Not specified Other No concurrent participation in another clinical trial
Sites / Locations
- Hollings Cancer Center at Medical University of South Carolina
Arms of the Study
Arm 1
Experimental
Gemcitabine and Irnotecan