Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

• The proportion of patients progression-free [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
  
  

• Survival time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
  Estimated using the method of Kaplan-Meier.
  
  
• Time to disease progression [ Time Frame: From randomization to documentation of disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]
  Estimated using the method of Kaplan-Meier.
  
  
• Duration of response (complete response [CR] or partial response [PR]) [ Time Frame: The date from which the patient's objective status if first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years ] [ Designated as safety issue: No ]
  
• Time to treatment failure [ Time Frame: From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years ] [ Designated as safety issue: No ]
  
• Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
  
  

PRIMARY OBJECTIVES:

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.