A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer
I. Determine the maximum tolerated dose of oblimersen when combined with standard dose
carboplatin and etoposide in patients with previously untreated extensive stage small cell
II. Determine the toxicity and feasibility of this regimen in these patients. III. Determine
potential antitumor activity of this regimen as assessed by objective response in these
OUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6,
and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6
courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0
Data will be summarized separately for each dose level, by severity, and type of toxicity.
Up to 3 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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