Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of imatinib mesylate when administered with irinotecan and cisplatin in patients with extensive stage small cell lung cancer. Determine the effect of imatinib mesylate on irinotecan metabolism by the cytochrome p450 system in these patients. Determine the response rate, time to progression, and survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral imatinib mesylate once or twice daily beginning on day 22 of course 1 and continuing until disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study within 12-18 months.

Official Title
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A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: imatinib mesylate
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer Extensive stage disease Measurable or evaluable indicator lesion No symptomatic or uncontrolled brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hemoglobin at least 10 g/dL Hepatic Bilirubin no greater than 1 mg/dL AST no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No uncontrolled cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study No other active cancer except previously treated carcinoma in situ, non -melanoma skin cancer, or stage I prostate cancer No ongoing or active infection No psychiatric illness or social situation that would preclude study No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate for rheumatoid arthritis) Endocrine therapy Not specified Radiotherapy At least 2 weeks since prior radiotherapy to major bone marrow-containing areas Surgery Not specified Other No concurrent warfarin for therapeutic anticoagulation Low-molecular weight heparin or heparin allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: imatinib mesylate|nan|
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extensive stage small cell lung cancer