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Brief Title: Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
Official Title: Phase II Study of Sunitinib (SU011248) in Patients With Small Cell Lung Cancer Who Are Either Chemo-naïve (Extensive Disease) or Have a "Sensitive" Relapse
Study ID: NCT00953459
Brief Summary: RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer. Secondary * To characterize the safety of sunitinib malate in these patients. Tertiary * To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound. OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy). Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis. After completion of study treatment, patients are followed up every 3 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Name: Egbert F. Smit, MD
Affiliation: Free University Medical Center
Role: PRINCIPAL_INVESTIGATOR