S0028, Gemcitabine and Paclitaxel in Treating Patients With 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.

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