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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
imatinib mesylate
irinotecan hydrochloride
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
July 23, 2008
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045604
Brief Title
Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official Title
A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee M. Krug, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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