Randomized Study of Docetaxel Versus Docetaxel Plus Genasenseā¢ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Deborah Braccia
Study Chair
Genta Incorporated
United States: Federal Government
CDR0000069185
NCT00030641
October 2001
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Whittingham Cancer Center | Norwalk, Connecticut 06856 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Winthrop University Hospital | Mineola, New York 11501 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
Arlington Cancer Center | Arlington, Texas 76012 |
John Wayne Cancer Institute at Saint John's Health Center | Santa Monica, California 90404 |
Yakima Regional Cancer Care Center | Yakima, Washington 89802 |
Texas Cancer Care | Fort Worth, Texas 76104 |
Pacific Hematology/Oncology | San Francisco, California 94115 |
Montgomery Cancer Center | Montgomery, Alabama 36106-3657 |
Morgantown Internal Medicine Group | Morgantown, West Virginia 26505 |
Little Rock Hematology-Oncology Associates | Little Rock, Arkansas 72205 |
Medical Oncology Care Associates | Orange, California 92668 |
Georgia Cancer Specialists - Northside Office | Atlanta, Georgia 30342 |
Summit Medical Group, P.A. | Summit, New Jersey 07901 |
East Bay Medical Oncology | Concord, California 94520 |
Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
Augusta Oncology Associates | Augusta, Georgia 30901 |
Hematology Oncology Services | New Orleans, Louisiana 70115 |
North General Hospital | New York, New York 10035 |
Charleston Cancer Center | Charleston, South Carolina 29406 |
Harold Simmons Cancer Center | Dallas, Texas 75390-8852 |