Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	MSKCC-02015 NCI-5653, NCT00045604, 5653

Objectives

1. Determine the maximum tolerated dose of imatinib mesylate when administered with irinotecan and cisplatin in patients with extensive stage small cell lung cancer.
2. Determine the effect of imatinib mesylate on irinotecan metabolism by the cytochrome p450 system in these patients.
3. Determine the response rate, time to progression, and survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed small cell lung cancer
  • Extensive stage disease



• Measurable or evaluable indicator lesion



• No symptomatic or uncontrolled brain or leptomeningeal involvement

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

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

Expected Enrollment

Approximately 18 patients will be accrued for this study within 12-18 months.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Lee Krug, MD, Protocol chair		Ph: 212-639-8420; 800-525-2225

Registry Information
Official Title		A Phase I Study of Imatinib (Gleevec) in Combination with Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
Trial Start Date		2002-07-02
Registered in ClinicalTrials.gov		NCT00045604
Date Submitted to PDQ		2002-07-11
Information Last Verified		2004-04-15
NCI Grant/Contract Number		N01-CM17105, P30-CA08748

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