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

Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency

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.

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