Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Gregory P. Kalemkerian, MD
University of Michigan Cancer Center
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|