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Brief Title: Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
Official Title: Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT00323362
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate. Secondary * Assess time to progression in patients treated with this regimen. * Assess overall survival and 1-year survival of patients treated with this regimen. * Assess the toxicity of this regimen in these patients. OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study. Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Name: Mika Sovak, MD, PhD
Affiliation: Rutgers Cancer Institute of New Jersey
Role: PRINCIPAL_INVESTIGATOR