Endometrial Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation of AZD6244 (NSC #748727) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
This phase II trial is studying how well selumetinib works in treating patients with recurrent or persistent endometrial cancer that has come back or is persistent. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the activity of AZD6244 (selumetinib) for patients with recurrent or persistent
endometrial cancer with the frequency of patients who survive progression-free for at least 6
months after initiating therapy or have objective tumor response.
II. To determine the nature and degree of toxicity of AZD6244 as assessed by CTCAE v3.0 in
this cohort of patients.
SECONDARY OBJECTIVE:
I. To determine the duration of progression-free survival and overall survival.
EXPLORATORY OBJECTIVES:
I. To explore the associations between select biomarkers and response to 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.
II. Mutations and single nucleotide polymorphisms in BRAF, KRAS2, FGFR2, PI3KCA, AKT1, AKT2,
AKT3 and PTEN in DNA from formalin-fixed and paraffin-embedded (FFPE) tumor and/or normal
blood cells.
III. Immunohistochemical expression of ERK, pERK, GSK3betta, pGSK3betta, PR-A, PR-B, pPR,
ER-alpha, ER-beta, BRAF, KRAS, PTEN, EGFR, pEGFR, EGF, PELP1 and MTA1s in FFPE tumor.
IV. To explore the relationship among the panel of biomarkers evaluated in this cohort
including mutations and single nucleotide polymorphisms in BRAF, KRAS2, FGFR2, PI3KCA, AKT1,
AKT2, AKT3 and PTEN as well as immunohistochemical expression of ERK, pERK, GSK3betta,
pGSK3betta, PR-A, PR-B, pPR, ER-alpha, ER-beta, BRAF, KRAS, PTEN, EGFR, pEGFR, EGF, PELP1 and
MTA1s.
OUTLINE: This is a multicenter study.
Patients receive selumetinib orally (PO) 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.
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