Overview
Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancerPhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Cisplatin
Imatinib Mesylate
Irinotecan
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed small cell lung cancer
- Extensive stage disease
- Measurable or evaluable indicator lesion
- No symptomatic or uncontrolled brain or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 4,000/mm3
- Platelet count at least 160,000/mm3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 1 mg/dL
- AST no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 5 times ULN
Renal
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No uncontrolled cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months
after study
- No other active cancer except previously treated carcinoma in situ, non -melanoma skin
cancer, or stage I prostate cancer
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study
- No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate
for rheumatoid arthritis)
Endocrine therapy
- Not specified
Radiotherapy
- At least 2 weeks since prior radiotherapy to major bone marrow-containing areas
Surgery
- Not specified
Other
- No concurrent warfarin for therapeutic anticoagulation
- Low-molecular weight heparin or heparin allowed