Finding studies
Finding studies
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Lead
Genta Incorporated
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
