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RATIONALE: AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- To assess the activity of MEK inhibitor AZD6244, in terms of progression-free survival rate for ≥ 6 months after initiating therapy or objective response rate, in patients with recurrent or persistent endometrial carcinoma.
- To determine the nature and degree of toxicity of this regimen in these patients as assessed by NCI CTCAE v3.0.
- To determine the duration of progression-free survival and overall survival of patients treated with this regimen.
- To explore the association between select biomarkers and response to MEK inhibitor AZD6244 (progression-free survival status > 6 months and objective tumor response), measures of clinical outcome (progression-free survival and overall survival), or disease status, including histologic cell type.
- To explore the relationship among a panel of biomarkers, including mutations and single nucleotide polymorphisms in BRAF, KRAS2, FGFR2, PI3KCA, AKT1, AKT2, AKT3, and PTEN as well as immunohistochemical expression of ERK, pERK, GSK3β, pGSK3β, PR-A, PR-B, pPR, ERα, ERβ, BRAF, KRAS, PTEN, EGFR, pEGFR, EGF, PELP1, and MTA1s.
OUTLINE: This is a multicenter study.
Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and archived tumor tissue samples are collected for biomarker studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
MEK inhibitor AZD6244, laboratory biomarker analysis
University of Colorado Cancer Center at UC Health Sciences Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:18:03-0400
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