Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter
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
Sites / Locations
- CCOP - Cedar Rapids Oncology Project
- CCOP - Kalamazoo
- Veterans Affairs Medical Center - East Orange
- Albert Einstein Clinical Cancer Center
- James P. Wilmot Cancer Center
- CCOP - Merit Care Hospital
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- University of Pennsylvania Cancer Center
- Fox Chase Cancer Center
- CCOP - Sioux Community Cancer Consortium
- CCOP - Scott and White Hospital
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- CCOP - Marshfield Medical Research and Education Foundation
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)