Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
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, 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 proven locally recurrent or advanced transitional cell carcinoma (TCC) of the urothelial tract (bladder, renal pelvis, or ureter) or TCC with squamous cell or glandular elements not amenable to curative treatment No pure squamous cell carcinoma or adenocarcinoma Regional or distant metastases after cystoprostatectomy No brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life expectancy: At least 3 months Hematopoietic: No hemorrhagic disorder Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known sensitivity to any products to be administered or E. coli derived products No prior other malignancy except inactive nonmelanoma skin cancer, adequately treated stage I or II cancer in complete remission, or early stage prostate cancer (not currently being treated) No illness or psychiatric condition that would preclude study or follow up Not previously entered in this study No active uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent biologic therapy No concurrent WBC transfusions Chemotherapy: No prior gemcitabine or docetaxel Other prior chemotherapy allowed Prior intravesical therapy allowed No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to renal pelvis or ureter allowed Surgery: See Disease Characteristics Cystoprostatectomy or nephroureterectomy for localized TCC allowed Other: No prior investigational drugs No other concurrent investigational therapy No concurrent acetaminophen for fever prophylaxis
Sites / Locations
- University of California San Diego
- Sacramento Center for Hematology and Medical Oncology
- Washington Cancer Institute
- Center for Hematology-Oncology
- Oncology-Hematology Associates of North Illinois, Ltd.
- Maine Center for Cancer Medicine and Blood Disorders
- St. Joseph Medical Center
- Hematology & Oncology Associates of Southern Michigan
- Hematology Oncology Associates of Central New York
- Memphis Cancer Center, Inc.
- Arlington Cancer Center
- Northern Virginia Oncology Group