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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
cisplatin
imatinib mesylate
irinotecan hydrochloride
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age Not specified Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy More than 6 weeks Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and/or ALT ≤ 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Gastrointestinal No concurrent untreated upper gastrointestinal bleeding that has not been fully investigated No gastrointestinal disease that would impair drug absorption Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior chemotherapy No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy No prior radiotherapy to more than 25% of marrow Surgery More than 3 weeks since prior major surgery No prior surgical procedure impairing absorption Other 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

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STI-571 with cisplatin and irinotecan

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2003
Last Updated
July 22, 2015
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052494
Brief Title
Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

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, recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STI-571 with cisplatin and irinotecan
Arm Type
Experimental
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
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age Not specified Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy More than 6 weeks Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and/or ALT ≤ 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Gastrointestinal No concurrent untreated upper gastrointestinal bleeding that has not been fully investigated No gastrointestinal disease that would impair drug absorption Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior chemotherapy No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy No prior radiotherapy to more than 25% of marrow Surgery More than 3 weeks since prior major surgery No prior surgical procedure impairing absorption Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D. Vincent, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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