Spots Global Cancer Trial Database for Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
Official Title: Randomized Study of Docetaxel Versus Docetaxel Plus Genasense™ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer
Study ID: NCT00030641
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. It is not yet known if docetaxel is more effective with or without oblimersen in treating non-small cell lung cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of docetaxel with or without oblimersen in treating patients who have relapsed or refractory non-small cell lung cancer that has been previously treated.
Detailed Description: OBJECTIVES: * Compare the survival of patients with non-small cell lung cancer treated with docetaxel with or without oblimersen (G3139). * Compare the proportion of major antitumor responses in patients treated with these regimens. * Compare the response duration and time to progression in patients treated with these regimens. * Compare the safety and clinical benefit of these regimens, in terms of changes in performance status and tumor-related symptoms, in these patients. * Compare the proportion of patients surviving 6 and 12 months after treatment with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to response to prior first-line chemotherapy regimen (progression vs stable disease, partial response, or complete response), ECOG performance status (0-1 vs 2), and prior paclitaxel treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oblimersen (G3139) IV continuously on days 1-7 and docetaxel IV over 1 hour on day 5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease upon completion of 8 courses may receive 8 or more additional courses at physician's discretion. * Arm II: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Upon completion of 8 courses, patients may continue to receive docetaxel off study at physician's discretion. Patients are followed every 9 weeks for up to 18 months. PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Montgomery Cancer Center, Montgomery, Alabama, United States
Little Rock Hematology-Oncology Associates, Little Rock, Arkansas, United States
East Bay Medical Oncology, Concord, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Medical Oncology Care Associates, Orange, California, United States
Pacific Hematology/Oncology, San Francisco, California, United States
John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
Whittingham Cancer Center, Norwalk, Connecticut, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Georgia Cancer Specialists - Northside Office, Atlanta, Georgia, United States
Augusta Oncology Associates, Augusta, Georgia, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Central Baptist Hospital, Lexington, Kentucky, United States
Hematology Oncology Services, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska, United States
Summit Medical Group, P.A., Summit, New Jersey, United States
Winthrop University Hospital, Mineola, New York, United States
North General Hospital, New York, New York, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
Charleston Cancer Center, Charleston, South Carolina, United States
Arlington Cancer Center, Arlington, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Harold Simmons Cancer Center, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Texas Cancer Care, Weatherford, Texas, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Yakima Regional Cancer Care Center, Yakima, Washington, United States
Morgantown Internal Medicine Group, Morgantown, West Virginia, United States
West Virginia University Hospitals, Morgantown, West Virginia, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, Canada
McGill University, Montreal, Quebec, Canada
L'Hopital Laval, Ste-Foy, Quebec, Canada
Medical Radiological Research Center RAMS, Kaluga Region, , Russian Federation
Russian Academy of Medical Sciences Cancer Research Center, Moscow, , Russian Federation
P.A. Hertzen Research Oncology Institute, Moscow, , Russian Federation
Municipal Oncological Dispensary, Saint Petersburg, , Russian Federation
Petrov Research Institute of Oncology, Saint Petersburg, , Russian Federation
Contact Details
Name: Deborah Braccia
Affiliation: Genta Incorporated
Role: STUDY_CHAIR
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