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

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ClinicalTrials.gov Identifier: NCT00045604
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: imatinib mesylate Drug: irinotecan hydrochloride Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
Study Start Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed small cell lung cancer

    • Extensive stage disease
  • Measurable or evaluable indicator lesion
  • No symptomatic or uncontrolled brain or leptomeningeal involvement



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • WBC at least 4,000/mm3
  • Platelet count at least 160,000/mm3
  • Hemoglobin at least 10 g/dL


  • 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


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled cardiac arrhythmia


  • 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


Biologic therapy

  • Not specified


  • No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate for rheumatoid arthritis)

Endocrine therapy

  • Not specified


  • At least 2 weeks since prior radiotherapy to major bone marrow-containing areas


  • Not specified


  • No concurrent warfarin for therapeutic anticoagulation

    • Low-molecular weight heparin or heparin allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045604

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Lee M. Krug, MD Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier: NCT00045604     History of Changes
Other Study ID Numbers: CDR0000256923
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Imatinib Mesylate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors