s0028, gemcitabine and paclitaxel in treating patients with advanced or recurrent cancer of the urinary tract

Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. giving more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract.

objectives: * determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase ii study. * determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients. * assess the toxicity and tolerability of this regimen in these elderly patients. * determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in these patients. * determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years. outline: this is a multicenter study. patients are stratified according to age (70 and over vs under 60). patients receive paclitaxel iv over 3 hours on day 1 and gemcitabine iv over 30 minutes on days 1 and 8. treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline. patients are followed every 3 months for 1 year and then every 6 months for 2 years. projected accrual: a total of 80 patients (60 age 70 and over and 20 under age 60) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed urothelial cancer * transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder, renal pelvis, ureter, or urethra) * previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes) disease or * locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible for further radiotherapy or surgery * measurable disease patient characteristics: age: * 70 and over or * under 60 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 no greater than upper limit of normal (uln) * aspartate aminotransferase (sgot) or alanine aminotransferase (sgpt) no greater than 2 times uln renal: * creatinine no greater than uln other: * hiv negative * no other concurrent life-threatening medical disorder that would preclude study participation * no other prior 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 in complete remission * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * prior adjuvant chemotherapy is allowed provided administered more than 10 years ago * no prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 28 days since prior radiotherapy and recovered surgery: * see disease characteristics * at least 28 days since prior surgery and recovered

Keywords: recurrent bladder cancer stage iv bladder cancer transitional cell carcinoma of the bladder squamous cell carcinoma of the bladder adenocarcinoma of the bladder recurrent urethral cancer anterior urethral cancer posterior urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter