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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with 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.

Eligibility Criteria:
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