Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function

OBJECTIVES:

- Determine the response rate of patients with progressive regional or metastatic
transitional cell carcinoma of the urothelium with renal insufficiency when treated with
paclitaxel and gemcitabine.

- Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3
courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27
months.

DISEASE CHARACTERISTICS:

- Histologically confirmed progressive regional or metastatic transitional cell
carcinoma of the urothelium

- Mixed histologies containing a component of transitional cell carcinoma allowed

- Bidimensionally measurable disease

- No clinical evidence of CNS metastases

- Clinically unsuspected organ-confined prostate cancer found at time of
cystoprostatectomy allowed

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase
normal OR

- Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR

- SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN

Renal:

- Creatinine no greater than 3.0 mg/dL

- Glomerular filtration rate no greater than 50 mL/min

Cardiovascular:

- No history of American Heart Association class III or IV heart disease

- No uncontrolled congestive heart failure

- No severe cardiac arrhythmias

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No preexisting peripheral neuropathy grade 2 or greater

- No active unresolved infection requiring parenteral antibiotics within the past 7 days

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior systemic biologic response modifier therapy for advanced disease

- Prior intravesical BCG for superficial disease allowed

Chemotherapy:

- Prior intravesical chemotherapy for superficial disease allowed

- No prior chemotherapy for advanced disease

- At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine,
doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV),
or cisplatin as a radiosensitizer

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery and recovered

Other:

- No concurrent hemodialysis