Bladder Cancer Clinical Trial
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.
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.
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
18 and over
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
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
Creatinine no greater than 3.0 mg/dL
Glomerular filtration rate no greater than 50 mL/min
No history of American Heart Association class III or IV heart disease
No uncontrolled congestive heart failure
No severe cardiac arrhythmias
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:
No prior systemic biologic response modifier therapy for advanced disease
Prior intravesical BCG for superficial disease allowed
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
At least 4 weeks since prior radiotherapy
No concurrent radiotherapy
See Disease Characteristics
At least 4 weeks since prior major surgery and recovered
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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