Status:
COMPLETED
Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Novartis Pharmaceuticals
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 imatini...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00248482
Start Date
February 1 2002
End Date
January 1 2008
Last Update
April 29 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379