Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
I. Determine the response rate, time to progression, and overall survival of patients with
recurrent small cell lung cancer treated with imatinib mesylate.
II. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in
patients treated with this drug.
III. Correlate individual patient variation in clinical (toxicity and/or activity),
pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative
laboratory study results) responses to this drug with genetic differences in proteins
involved in drug response (transport, metabolism, and/or mechanism of action).
OUTLINE: This is a multicenter study. Patients are stratified according to length of prior
therapy (less than 3 months vs at least 3 months).
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the
absence of disease progression or unacceptable toxicity.
*Patients are followed every 3 months until disease progression and then every 6 months for
up to 3 years after registration.
NOTE: *Patients who develop CNS metastasis as the only site of disease progression receive
therapeutic whole-brain radiotherapy and then resume study therapy.
PROJECTED ACCRUAL: A total of 41 patients for stratum I will be accrued within 21 months and
50 patients for stratum II will be accrued within 25 months for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of patients progression-free
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
North Central Cancer Treatment Group
United States: Food and Drug Administration
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