Overview

Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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 cancer
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
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