- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00052949
Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- North Central Cancer Treatment Group
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily for 28 days.
Courses continue in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients progression-free
Time Frame: 16 weeks
|
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival time
Time Frame: From registration to death due to any cause, assessed up to 3 years
|
Estimated using the method of Kaplan-Meier.
|
From registration to death due to any cause, assessed up to 3 years
|
Time to disease progression
Time Frame: From randomization to documentation of disease progression, assessed up to 3 years
|
Estimated using the method of Kaplan-Meier.
|
From randomization to documentation of disease progression, assessed up to 3 years
|
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
|
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
|
|
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
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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
|
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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
Time Frame: Up to 3 years
|
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alex Adjei, North Central Cancer Treatment Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- NCI-2012-01801 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA025224 (U.S. NIH Grant/Contract)
- CDR0000269156
- NCCTG-N0124
- CALGB-30201
- N0124 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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