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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria
Response rate every 4 weeks according to RECIST criteria
Duration of progression-free survival
Duration of response
Duration of survival
Toxicity according to NCI CTCAE version 3.0
Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response
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