A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed extensive stage small cell lung cancer

- Incurable but amenable to treatment with chemotherapy

- c-kit positive by immunohistochemistry of original biopsy or other metastatic
site

- At least one unidimensionally measurable lesion

- > 20 mm by conventional techniques or > 10 mm by spiral CT scan

- No prior radiotherapy to target measurable lesion(s), unless there is documented
disease progression

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- ECOG 0-1 OR

- Karnofsky 70-100%

Life expectancy

- More than 6 weeks

Hematopoietic

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin normal

- AST and/or ALT ≤ 2.5 times upper limit of normal

Renal

- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Gastrointestinal

- No concurrent untreated upper gastrointestinal bleeding that has not been fully
investigated

- No gastrointestinal disease that would impair drug absorption

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception prior to, during, and for 3
months after study participation

- No history of ototoxicity

- No history of peripheral neuropathy

- No traumatic injury within the past 21 days

- No ongoing or active infection

- No other concurrent significant medical condition that would preclude study
participation

- No concurrent psychiatric condition or social situation that would preclude study
compliance

- No other malignancy within the past 5 years except treated nonmelanoma skin cancer,
carcinoma in situ, or stage A prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to more than 25% of marrow

Surgery

- More than 3 weeks since prior major surgery

- No prior surgical procedure impairing absorption

Other

- No prior c-kit-targeted therapy

- No concurrent therapeutic dose of warfarin

- Mini-dose warfarin for prophylaxis and low-molecular weight heparin allowed

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No concurrent amifostine

- No other concurrent anticancer therapy