A Randomized Phase II Study Of Carboplatin And Etoposide With Or Without G3139 (NSC #683428, IND #58842) In Patients With Extensive Stage Small Cell Lung Cancer
I. To assess the percentage of patients with extensive stage small cell lung cancer treated
with G3139 (oblimersen sodium), carboplatin, and etoposide who live longer than 12 months.
I. To assess the response rate of patients treated with G3139, carboplatin, and etoposide.
II. To assess the toxicity of the combination of G3139, carboplatin, and etoposide.
III. To compare the toxicity observed to that seen in a cohort of patients treated with
carboplatin and etoposide alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oblimersen sodium intravenously (IV) continuously on days 1-8,
carboplatin IV over 30 minutes on day 6, and etoposide IV over 60 minutes on days 6-8.
Treatment repeats every 21 days for 6 courses in the absence of disease progression or
ARM II: Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 60
minutes on days 1-3. Treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, and
then every 6 months for 2 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients who live longer than 12 months
Kaplan-Meier curves will be used will be used to describe overall survival and failure-free survival.
Up to 3 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Cancer and Leukemia Group B||Chicago, Illinois 60606|