Lung Cancer Clinical Trial
Official title:
Randomized Study of Docetaxel Versus Docetaxel Plus Genasenseā¢ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer
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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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