Extensive Stage Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer
PRIMARY OBJECTIVES:
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
lung cancer.
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
patients.
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
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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