Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00030641|
Recruitment Status : Unknown
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
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 or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: oblimersen sodium Drug: docetaxel||Phase 2 Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030641
|Study Chair:||Deborah Braccia||Genta Incorporated|