Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
- Conditions
- Bladder CancerTransitional Cell Cancer of the Renal Pelvis and Ureter
- Registration Number
- NCT00005958
- Lead Sponsor
- Amgen
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or advanced urothelium cancer.
- Detailed Description
OBJECTIVES: I. Determine the efficacy of gemcitabine, docetaxel, and filgrastim (G-CSF) in patients with locally recurrent or advanced transitional cell carcinoma of the urothelial tract. II. Determine the toxicity of this regimen in these patients. III. Determine the disease-free and overall survival of this patient population treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no). Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond to treatment may undergo surgery and 6-8 weeks later receive 2 more courses of chemotherapy. Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 23-40 patients who have not received prior chemotherapy and 23 patients who have received prior chemotherapy will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
University of California San Diego
🇺🇸La Jolla, California, United States
Center for Hematology-Oncology
🇺🇸Boca Raton, Florida, United States
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
Hematology Oncology Associates of Central New York
🇺🇸Syracuse, New York, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Northern Virginia Oncology Group
🇺🇸Fairfax, Virginia, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Oncology-Hematology Associates of North Illinois, Ltd.
🇺🇸Gurnee, Illinois, United States
Memphis Cancer Center, Inc.
🇺🇸Memphis, Tennessee, United States
Hematology & Oncology Associates of Southern Michigan
🇺🇸Jackson, Michigan, United States
Sacramento Center for Hematology and Medical Oncology
🇺🇸Sacramento, California, United States