Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium

Inclusion 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