Malignant Pleural Effusion Clinical Trial
Official title:
Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma
AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.
PRIMARY OBJECTIVES:
I. To determine the 12-week progression-free survival rate of patients with extensive stage
small cell lung cancer treated with AZD0530.
SECONDARY OBJECTIVES:
I. To determine the response rate in patients treated with this drug. II. To determine the
overall survival and time-to-progression in patients treated with this drug.
III. To determine the adverse events of AZD0530 in these patients IV. To determine the effect
of AZD0530 treatment on levels of circulating tumor cells in these patients.
V. To determine potential predictive markers of response in circulating tumor cells after
treatment with this drug.
VI. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in
patients treated with this drug.
TERTIARY OBJECTIVES:
I. To determine the effect of AZD0530 treatment on levels of circulating tumor cells.
II. To determine potential predictive markers of response in circulating tumor cells after
treatment with this drug.
III. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in
patients treated with this drug.
OUTLINE: Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease
progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically
during study to determine levels of circulating tumor cells for defined translational
studies.
After completion of study therapy, patients are followed periodically for up to 2 years.
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