• Overall response rate (complete and partial response) as assessed by RECIST criteria [ Designated as safety issue: No ]
  

• Time to tumor progression [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Overall percentage of patients experiencing ≥ grade 3 toxicity [ Designated as safety issue: Yes ]
  
• Overall percentage of patients experiencing toxicity within a clinically significant category (including neutropenia, neutropenic fever, and neuropathy) [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• Determine the clinical efficacy of imatinib mesylate and paclitaxel in older patients with stage IIIB-IV non-small cell lung cancer.

Secondary

• Determine the safety of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive oral imatinib mesylate once daily on days 1-4, 8-11, and 15-18 and paclitaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity or progressive disease.

After completion of study therapy, patients are followed monthly.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:

  • Stage IIIB with pleural effusion OR stage IV disease

    • Prior surgery alone for early stage disease allowed provided disease has relapsed and is now considered to be advanced
• Measurable disease

• No uncontrolled brain metastasis

  • Patients with known brain metastasis must have completed treatment with surgery, radiotherapy, or both

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Platelet count > 100,000/mm³
• Absolute neutrophil count > 1,500/mm³
• Bilirubin < 1.25 times upper limit of normal (ULN)
• AST and ALT < 2.5 times ULN
• Creatinine < 1.5 times ULN
• Fertile patients must use effective contraception
• No symptomatic neuropathy ≥ grade 2
• No other primary malignancy within the past 5 years except for basal cell carcinoma, cervical carcinoma in situ, or other primary malignancy not considered clinically significant and requiring active intervention
• No New York Heart Association class III or IV congestive heart failure
• No myocardial infarction within the past 6 months
• No serious or uncontrolled disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
• No chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
• No significant history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 6 months since prior adjuvant therapy, neoadjuvant therapy, or chemoradiotherapy for NSCLC
• No prior chemotherapy for advanced NSCLC
• No prior radiotherapy to > 25% of bone marrow
• More than 2 weeks since prior major surgery
• No concurrent corticosteroids

• No concurrent therapeutic anticoagulation with warfarin

  • Prophylactic anticoagulation therapy with low molecular weight heparin or warfarin (e.g., 1 mg daily) allowed
• No other concurrent anticancer agents (e.g., chemotherapy or biologic therapy)
• No other concurrent investigational therapy
• No concurrent consumption of grapefruit juice or grapefruit-containing products