Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Recurrent Small Cell Lung Cancer

In brief

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

Key facts

Study ID

NCT00052949

Run by

National Cancer Institute (NCI)

People needed

91

Starts

2003-05-01

Last updated by the study team

2013-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed small cell lung cancer (SCLC)
• No mixed histology
• Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
• c-Kit positive by immunohistochemistry (at least 1+)
• At least 1 unidimensionally measurable lesion
• Longest diameter at least 20 mm
• No uncontrolled CNS metastasis
• Treated CNS metastasis allowed
• Performance status - ECOG 0-2
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 9 g/dL
• Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Direct bilirubin no greater than ULN
• Creatinine no greater than 1.5 times ULN
• No unstable angina pectoris
• No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40%
• No myocardial infarction within the past 3 months
• No uncontrolled infection
• No other malignancy within the past 3 years except skin cancer or localized prostate cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study participation
• See Disease Characteristics
• More than 3 weeks since prior chemotherapy

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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