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Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Gleevec™
irinotecan
Sponsored by
Barbara Ann Karmanos Cancer Institute
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

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer (SCLC) Extensive stage disease, defined by 1 of the following criteria: Disease extends beyond one hemithorax and regional lymph nodes Cytologically positive pleural effusion Meets 1 of the following criteria: Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy Evaluable disease No history of untreated or symptomatic brain or leptomeningeal metastases Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy PATIENT CHARACTERISTICS: Performance status SWOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8 g/dL Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN AP ≤ 5 times ULN AND AST and ALT normal No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal Creatinine normal OR Creatinine clearance ≥ 65 mL/min Cardiovascular No uncontrolled congestive heart failure No uncontrolled angina No myocardial infarction and/or stroke within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No symptomatic edema from any etiology No known HIV positivity No other serious medical illness No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy for SCLC Endocrine therapy No concurrent routine systemic corticosteroids Radiotherapy See Disease Characteristics At least 2 weeks since prior palliative radiotherapy Surgery More than 2 weeks since prior major surgery Other No concurrent therapeutic anticoagulation with warfarin Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry No other concurrent participation in another study of an investigational agent

Sites / Locations

  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irinotecan, Cisplatin & Gleevec™

Arm Description

Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Tolerability of Gleevec maintenance therapy
Response rate as measured by RECIST at

Full Information

First Posted
November 3, 2005
Last Updated
April 25, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI), Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00248482
Brief Title
Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official Title
Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI), Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back. PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin. Secondary Determine the overall survival of patients treated with this regimen. Determine the tolerability of imatinib mesylate maintenance therapy in these patients. Determine the response rate in patients treated with irinotecan and cisplatin. OUTLINE: This is a multicenter study. Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (partial or complete) or stable disease proceed to maintenance therapy. Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months in the absence of disease progression or unacceptable toxicity. Some patients may continue to receive therapy for up to 1 year. After completion of study treatment, patients are followed for 4 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan, Cisplatin & Gleevec™
Arm Type
Experimental
Arm Description
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol ®, Platinol®-AQ, CDDP
Intervention Description
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Gleevec™
Other Intervention Name(s)
STI-571, imatinib mesylate
Intervention Description
Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
Intervention Type
Drug
Intervention Name(s)
irinotecan
Other Intervention Name(s)
Camptosar®, Camptothecin-11, CPT-11
Intervention Description
Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
at 4 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
at least 4 months after discontinuation of treatment
Title
Tolerability of Gleevec maintenance therapy
Time Frame
30 days after completion of study treatment
Title
Response rate as measured by RECIST at
Time Frame
Baseline and every 8 weeks during study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer (SCLC) Extensive stage disease, defined by 1 of the following criteria: Disease extends beyond one hemithorax and regional lymph nodes Cytologically positive pleural effusion Meets 1 of the following criteria: Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy Evaluable disease No history of untreated or symptomatic brain or leptomeningeal metastases Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy PATIENT CHARACTERISTICS: Performance status SWOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8 g/dL Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN AP ≤ 5 times ULN AND AST and ALT normal No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal Creatinine normal OR Creatinine clearance ≥ 65 mL/min Cardiovascular No uncontrolled congestive heart failure No uncontrolled angina No myocardial infarction and/or stroke within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No symptomatic edema from any etiology No known HIV positivity No other serious medical illness No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy for SCLC Endocrine therapy No concurrent routine systemic corticosteroids Radiotherapy See Disease Characteristics At least 2 weeks since prior palliative radiotherapy Surgery More than 2 weeks since prior major surgery Other No concurrent therapeutic anticoagulation with warfarin Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry No other concurrent participation in another study of an investigational agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirish M. Gadgeel, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

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Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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