Spots Global Cancer Trial Database for Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title: A Phase II Study of Docetaxel and Vinorelbine in Advanced Non-Small Cell Lung Carcinoma
Study ID: NCT00006215
Conditions
Study Description
Brief Summary: 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 tumor cells. 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 plus filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Detailed Description: OBJECTIVES: I. Determine the response to docetaxel and vinorelbine with filgrastim (G-CSF) support in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival and time to tumor progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes and docetaxel IV over 1 hour on day 1 and filgrastim (G-CSF) subcutaneously daily on days 2-12 or until blood counts recover. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gould Medical Group, Modesto, California, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, United States
Georgia Cancer Treatment Center, P.C., Riverdale, Georgia, United States
Oncology and Hematology Associates, Westwood, Kansas, United States
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, United States
Hematology-Oncology Associates of Rockland, P.C., New City, New York, United States
New York Medical College, Valhalla, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Community Oncology Group, Independence, Ohio, United States
CCOP - Dayton, Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
Charleston Hematology-Oncology, P.A., Charleston, South Carolina, United States
Trident Palmetto Hematology/Oncology, North Charleston, South Carolina, United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group, Memphis, Tennessee, United States
Texas Cancer Care, Fort Worth, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Hematology & Oncology Associates of Virginia, Richmond, Virginia, United States
Morgantown Internal Medicine Group, Morgantown, West Virginia, United States
Contact Details
Name: Barbara Allen, DVM, MBA, PharmD
Affiliation: Amgen
Role: STUDY_CHAIR
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