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

OBJECTIVES:

- Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among
patients with regional or distant metastases of transitional cell carcinoma of the
urothelium or local/regional recurrence after cystoprostatectomy.

- Determine response in patients who receive GTP as the initial chemotherapeutic treatment
as well as in patients who have received prior chemotherapy.

- Determine response duration, freedom from progression, and overall survival.

- Assess the toxicity of GTP.

OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy
(yes vs no).

Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and
gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving a partial response or complete response undergo surgical restaging and
debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy.

After completion of study treatment, patients are followed every 3 months for 1 year and then
every 6 months thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

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