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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00052494
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 23, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining cisplatin, irinotecan, and imatinib mesylate 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 cisplatin and irinotecan in patients with extensive stage small cell lung cancer.
  • Determine the recommended phase II dose of imatinib mesylate in patients treated with this regimen.
  • Determine the response rate, median duration of response, progression-free survival, median survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate.

Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 4 courses. Patients also receive oral imatinib mesylate daily continually for one week prior to, during, and after chemotherapy in the absence of 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 at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose (one dose level below the MTD).

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1-2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer
Study Start Date : April 2003
Actual Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: STI-571 with cisplatin and irinotecan Drug: cisplatin Drug: imatinib mesylate Drug: irinotecan hydrochloride

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed extensive stage small cell lung cancer

    • Incurable but amenable to treatment with chemotherapy
    • c-kit positive by immunohistochemistry of original biopsy or other metastatic site
  • At least one unidimensionally measurable lesion

    • > 20 mm by conventional techniques or > 10 mm by spiral CT scan
    • No prior radiotherapy to target measurable lesion(s), unless there is documented disease progression
  • No known brain metastases



  • Not specified

Performance status

  • ECOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy

  • More than 6 weeks


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


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


  • No concurrent untreated upper gastrointestinal bleeding that has not been fully investigated
  • No gastrointestinal disease that would impair drug absorption


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception prior to, during, and for 3 months after study participation
  • No history of ototoxicity
  • No history of peripheral neuropathy
  • No traumatic injury within the past 21 days
  • No ongoing or active infection
  • No other concurrent significant medical condition that would preclude study participation
  • No concurrent psychiatric condition or social situation that would preclude study compliance
  • No other malignancy within the past 5 years except treated nonmelanoma skin cancer, carcinoma in situ, or stage A prostate cancer


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of marrow


  • More than 3 weeks since prior major surgery
  • No prior surgical procedure impairing absorption


  • No prior c-kit-targeted therapy
  • No concurrent therapeutic dose of warfarin

    • Mini-dose warfarin for prophylaxis and low-molecular weight heparin allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No concurrent amifostine
  • No other concurrent anticancer therapy

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 identifier (NCT number): NCT00052494

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
National Cancer Institute (NCI)
Study Chair: Mark D. Vincent, MD London Health Sciences Centre

Responsible Party: University Health Network, Toronto Identifier: NCT00052494     History of Changes
Other Study ID Numbers: PMH-PHL-008
CDR0000258487 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by University Health Network, Toronto:
extensive stage small cell lung cancer
recurrent 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