Back to resultsImatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
Primary Purpose
Recurrent Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed small cell lung cancer (SCLC) No mixed histology Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed) c-Kit positive by immunohistochemistry (at least 1+) At least 1 unidimensionally measurable lesion Longest diameter at least 20 mm No uncontrolled CNS metastasis Treated CNS metastasis allowed Performance status - ECOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Total bilirubin no greater than 1.5 times upper limit of normal (ULN) Direct bilirubin no greater than ULN Creatinine no greater than 1.5 times ULN No unstable angina pectoris No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40% No myocardial infarction within the past 3 months No uncontrolled infection No other malignancy within the past 3 years except skin cancer or localized prostate cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study participation See Disease Characteristics More than 3 weeks since prior chemotherapy More than 2 weeks since prior radiotherapy No concurrent radiotherapy(including palliative therapy for bone pain) Concurrent whole-brain radiotherapy for CNS progression allowed More than 3 weeks since prior major surgery No prior imatinib mesylate
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (imatinib mesylate)
Arm Description
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
The proportion of patients progression-free
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Secondary Outcome Measures
Survival time
Estimated using the method of Kaplan-Meier.
Time to disease progression
Estimated using the method of Kaplan-Meier.
Duration of response (complete response [CR] or partial response [PR])
Time to treatment failure
Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Full Information
NCT ID
NCT00052949
First Posted
January 24, 2003
Last Updated
October 7, 2013
Sponsor
National Cancer Institute (NCI)
Collaborators
Cancer and Leukemia Group B
1. Study Identification
Unique Protocol Identification Number
NCT00052949
Brief Title
Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
Official Title
Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Cancer and Leukemia Group B
4. Oversight
5. Study Description
Brief Summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the response rate, time to progression, and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate.
II. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug.
III. Correlate individual patient variation in clinical (toxicity and/or activity), pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to this drug with genetic differences in proteins involved in drug response (transport, metabolism, and/or mechanism of action).
OUTLINE: This is a multicenter study. Patients are stratified according to length of prior therapy (less than 3 months vs at least 3 months).
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
*Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration.
NOTE: *Patients who develop CNS metastasis as the only site of disease progression receive therapeutic whole-brain radiotherapy and then resume study therapy.
PROJECTED ACCRUAL: A total of 41 patients for stratum I will be accrued within 21 months and 50 patients for stratum II will be accrued within 25 months for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
91 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (imatinib mesylate)
Arm Type
Experimental
Arm Description
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
The proportion of patients progression-free
Description
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Survival time
Description
Estimated using the method of Kaplan-Meier.
Time Frame
From registration to death due to any cause, assessed up to 3 years
Title
Time to disease progression
Description
Estimated using the method of Kaplan-Meier.
Time Frame
From randomization to documentation of disease progression, assessed up to 3 years
Title
Duration of response (complete response [CR] or partial response [PR])
Time Frame
The date from which the patient's objective status if first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years
Title
Time to treatment failure
Time Frame
From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years
Title
Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
Description
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed small cell lung cancer (SCLC)
No mixed histology
Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
c-Kit positive by immunohistochemistry (at least 1+)
At least 1 unidimensionally measurable lesion
Longest diameter at least 20 mm
No uncontrolled CNS metastasis
Treated CNS metastasis allowed
Performance status - ECOG 0-2
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL
Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
Direct bilirubin no greater than ULN
Creatinine no greater than 1.5 times ULN
No unstable angina pectoris
No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40%
No myocardial infarction within the past 3 months
No uncontrolled infection
No other malignancy within the past 3 years except skin cancer or localized prostate cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study participation
See Disease Characteristics
More than 3 weeks since prior chemotherapy
More than 2 weeks since prior radiotherapy
No concurrent radiotherapy(including palliative therapy for bone pain)
Concurrent whole-brain radiotherapy for CNS progression allowed
More than 3 weeks since prior major surgery
No prior imatinib mesylate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Adjei
Organizational Affiliation
North Central Cancer Treatment Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Central Cancer Treatment Group
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
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