- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248482
Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-0942
- University of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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: Irinotecan, Cisplatin & Gleevec™
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 |
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Other Names:
Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
Other Names:
Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: at 4 months
|
at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: at least 4 months after discontinuation of treatment
|
at least 4 months after discontinuation of treatment
|
Tolerability of Gleevec maintenance therapy
Time Frame: 30 days after completion of study treatment
|
30 days after completion of study treatment
|
Response rate as measured by RECIST at
Time Frame: Baseline and every 8 weeks during study treatment
|
Baseline and every 8 weeks during study treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study 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
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Topoisomerase I Inhibitors
- Cisplatin
- Irinotecan
- Imatinib Mesylate
- Camptothecin
Other Study ID Numbers
- CDR0000445222
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-C-2461 (Other Identifier: Barbara Ann Karmanos Cancer Institute)
- WSU-UMCC-2001-066
- CST1571B US93 (Other Identifier: Novartis Pharmaceuticals)
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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