Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, regional transitional cell cancer of the renal pelvis and ureter, stage IV bladder cancer, recurrent bladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, or ureter) or TCC with squamous or glandular elements No pure squamous cell carcinoma or adenocarcinoma Disease not amenable to local curative treatment Regional or distant metastases of TCC of the urothelium OR local/regional recurrence after cystectomy, cystoprostatectomy, nephroureterectomy, or ureterectomy If regional metastases present alone, histological confirmation of the metastases is required No clinically evident brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0 or 1 Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.6 mg/mL Bilirubin ≤ 1.8 mg/mL SGOT ≤ 3 times upper limit of normal Life expectancy > 3 months No known sensitivity to E. coli-derived products No other prior or concurrent malignancy except active/inactive nonmelanoma skin cancer, adequately treated stage I or II cancer currently in complete remission, or observation-only early-stage prostate cancer No other serious medical illness that would limit survival to < 3 months No psychiatric condition that would limit compliance with study requirements No active uncontrolled bacterial, viral, or fungal infection unless corrected or controlled No hemorrhagic disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior systemic chemotherapy regimen Prior intravesical therapy allowed Prior definitive radiation to renal pelvis, ureter, or bladder allowed No concurrent chemotherapy with nonstudy drugs
Sites / Locations
- Carolinas Hematology-Oncology Associates
- Regional Cancer Center
- Wake Forest University Comprehensive Cancer Center