Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back.

PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI); Novartis Pharmaceuticals
• Treatments: Camptothecin; Cisplatin; Imatinib Mesylate; Irinotecan

Criteria

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