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| Sponsor: | Genta Incorporated |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030641 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: oblimersen sodium Drug: docetaxel |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| 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 Start Date: | October 2001 |
OBJECTIVES:
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of non-small lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent corticosteroids* except for the following conditions:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Montgomery Cancer Center | |
| Montgomery, Alabama, United States, 36106-2801 | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Arkansas | |
| Little Rock Hematology-Oncology Associates | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| East Bay Medical Oncology | |
| Concord, California, United States, 94520 | |
| John Wayne Cancer Institute at Saint John's Health Center | |
| Santa Monica, California, United States, 90404 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095 | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| Pacific Hematology/Oncology | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80010 | |
| United States, Connecticut | |
| Whittingham Cancer Center | |
| Norwalk, Connecticut, United States, 06856 | |
| United States, Florida | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33805 | |
| United States, Georgia | |
| Augusta Oncology Associates | |
| Augusta, Georgia, United States, 30901 | |
| Georgia Cancer Specialists - Northside Office | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Louisiana | |
| Hematology Oncology Services | |
| New Orleans, Louisiana, United States, 70115 | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Nebraska | |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114-4199 | |
| United States, New Jersey | |
| Summit Medical Group, P.A. | |
| Summit, New Jersey, United States, 07901 | |
| United States, New York | |
| North General Hospital | |
| New York, New York, United States, 10035 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| United States, Oklahoma | |
| Veterans Affairs Medical Center - Oklahoma City | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, South Carolina | |
| Charleston Cancer Center | |
| Charleston, South Carolina, United States, 29406 | |
| United States, Texas | |
| Arlington Cancer Center | |
| Arlington, Texas, United States, 76012-2510 | |
| Harold Simmons Cancer Center | |
| Dallas, Texas, United States, 75390-8852 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Texas Cancer Care | |
| Weatherford, Texas, United States, 76086 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-5048 | |
| Yakima Regional Cancer Care Center | |
| Yakima, Washington, United States, 98902 | |
| United States, West Virginia | |
| Morgantown Internal Medicine Group | |
| Morgantown, West Virginia, United States, 26505 | |
| West Virginia University Hospitals | |
| Morgantown, West Virginia, United States, 26506-9162 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| L'Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Russian Federation | |
| Russian Academy of Medical Sciences Cancer Research Center | |
| Moscow, Russian Federation, 115478 | |
| Municipal Oncological Dispensary | |
| Saint Petersburg, Russian Federation, 197022 | |
| P.A. Hertzen Research Oncology Institute | |
| Moscow, Russian Federation, 125284 | |
| Petrov Research Institute of Oncology | |
| Saint Petersburg, Russian Federation, 197758 | |
| Medical Radiological Research Center RAMS | |
| Kaluga Region, Russian Federation, 249020 | |
| Study Chair: | Deborah Braccia | Genta Incorporated |
More Information
| Study ID Numbers: | CDR0000069185, GENTA-GN304, NCI-G01-2046, UCLA-0301058 |
| Study First Received: | February 14, 2002 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00030641 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |