Combination Chemotherapy and Imatinib Mesylate 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: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining cisplatin, irinotecan, and imatinib mesylate in treating patients who have extensive-stage small cell lung cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Imatinib Mesylate; Irinotecan

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