• Study treatment feasibility [ Designated as safety issue: No ]
  

• Objective response rate (confirmed and unconfirmed complete and partial response) [ Designated as safety issue: No ]
  
• Survival at 2 years [ Designated as safety issue: No ]
  
• Toxicity and tolerability [ Designated as safety issue: Yes ]
  
• Feasibility of standardized self-report measures of comorbidity, depression, and functional status [ Designated as safety issue: No ]
  
• Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age [ Designated as safety issue: No ]
  

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.

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)
• SGOT or 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