Bladder Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Summary
 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.
Full Description
 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
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There are 16 Locations for this study
Cedar Rapids Iowa, 52403, United States
Kalamazoo Michigan, 49007, United States
East Orange New Jersey, 07019, United States
Bronx New York, 10461, United States
Rochester New York, 14642, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Sioux Falls South Dakota, 57104, United States
Temple Texas, 76508, United States
Green Bay Wisconsin, 54301, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
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