Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00030641
- Lead Sponsor
- Genta Incorporated
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
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
Scroll for more (34 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States