Extensive Stage Small Cell Lung Cancer Clinical Trial
Official title:
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
This phase II trial studies how well carboplatin and etoposide with or without oblimersen sodium works in treating patients with extensive stage small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as oblimersen sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Giving carboplatin and etoposide together with oblimersen sodium may kill not tumor cells
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
unacceptable toxicity.
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
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