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Clinical Trial Summary

Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.


Clinical Trial Description

OBJECTIVES:

I. Determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer.

II. Determine the toxicity of this regimen in these patients. III. Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00009971
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date November 2000

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