Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
With
PRIMARY OBJECTIVES: I. To assess the activity of cediranib (cediranib maleate) in patients with either persistent or recurrent endometrial carcinoma. II. To determine the frequency and degree of toxicity of cediranib as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.0 in this cohort of patients. SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival and overall survival. II. To estimate the probability of response without restriction on the duration of response documentation since study enrollment. TERTIARY OBJECTIVES: I. To determine if the response to cediranib correlates with high-expression of its receptor targets (e.g., vascular endothelial growth factor receptor \[VEGFR\] \[1, 2, 3\] and platelet derived growth factor receptor \[PDGFR\]). II. To determine if the response to cediranib correlates with high endogenous circulating plasma levels of VEGFA, low-levels of its endogenous inhibitor, soluble fms-related tyrosine kinase 3 (sFlt-1) (the truncated, circulating portion of VEGFR-1), or circulating tissue factor (TF) or circulating prostate apoptosis response-4 (Par-4), both potential markers of tumor progression. III. To determine if a high-expression of VEGFA on pre-treatment tumor specimens correlates with response to cediranib. IV. To determine if expression of phosphorylated mitogen activated protein kinase (ERK) 1 and 2, c-Jun, signal transducer and activator of transcription 3 (Stat3), protein kinase C (PKC), and phosphorylated ribosomal protein S6 (p70S6) kinase correlates with resistance or sensitivity to cediranib. OUTLINE: Patients receive cediranib maleate orally (PO) daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
