Lung Cancer Clinical Trial
Official title:
A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Exisulind may make tumor cells more sensitive to chemotherapy.
Combining chemotherapy with exisulind may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind
in treating patients who have extensive-stage small cell lung cancer.
OBJECTIVES:
- Determine the percentage of patients with extensive stage small cell lung cancer who
live more than 12 months after treatment with carboplatin, etoposide, and exisulind.
- Determine the response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes
on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 2 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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