Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, recurrent small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer (SCLC) Extensive stage disease, defined by 1 of the following criteria: Disease extends beyond one hemithorax and regional lymph nodes Cytologically positive pleural effusion Meets 1 of the following criteria: Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy Evaluable disease No history of untreated or symptomatic brain or leptomeningeal metastases Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy PATIENT CHARACTERISTICS: Performance status SWOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8 g/dL Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN AP ≤ 5 times ULN AND AST and ALT normal No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal Creatinine normal OR Creatinine clearance ≥ 65 mL/min Cardiovascular No uncontrolled congestive heart failure No uncontrolled angina No myocardial infarction and/or stroke within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No symptomatic edema from any etiology No known HIV positivity No other serious medical illness No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy for SCLC Endocrine therapy No concurrent routine systemic corticosteroids Radiotherapy See Disease Characteristics At least 2 weeks since prior palliative radiotherapy Surgery More than 2 weeks since prior major surgery Other No concurrent therapeutic anticoagulation with warfarin Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry No other concurrent participation in another study of an investigational agent
Sites / Locations
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Experimental
Irinotecan, Cisplatin & Gleevec™
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles