Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
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|ClinicalTrials.gov Identifier: NCT00005958|
Recruitment Status : Unknown
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 20, 2004
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter||Biological: filgrastim Drug: docetaxel Drug: gemcitabine hydrochloride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim|
|Study Start Date :||October 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005958
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92093|
|Sacramento Center for Hematology and Medical Oncology|
|Sacramento, California, United States, 95819|
|United States, District of Columbia|
|Washington Cancer Institute|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Center for Hematology-Oncology|
|Boca Raton, Florida, United States, 33486|
|United States, Illinois|
|Oncology-Hematology Associates of North Illinois, Ltd.|
|Gurnee, Illinois, United States, 60031|
|United States, Maine|
|Maine Center for Cancer Medicine and Blood Disorders|
|Scarborough, Maine, United States, 04074|
|United States, Maryland|
|St. Joseph Medical Center|
|Towson, Maryland, United States, 21204|
|United States, Michigan|
|Hematology & Oncology Associates of Southern Michigan|
|Jackson, Michigan, United States, 49201|
|United States, New York|
|Hematology Oncology Associates of Central New York|
|Syracuse, New York, United States, 13217-6962|
|United States, Tennessee|
|Memphis Cancer Center, Inc.|
|Memphis, Tennessee, United States, 38119|
|United States, Texas|
|Arlington Cancer Center|
|Arlington, Texas, United States, 76012|
|United States, Virginia|
|Northern Virginia Oncology Group|
|Fairfax, Virginia, United States, 22031|
|Study Chair:||Jennifer Tam||Amgen|