Clinical trial NCT02093546: Biospecimen Collection in Assessing the Effect of Trametinib With or Without Uprosertib on Biomarkers in Patients With Persistent or Recurrent Endometrial Cancer Enrolled on Trial GOG02290
Official title: A Translational Companion Protocol to GOG229O: A Randomized Phase II Study With a Safety Lead-In to Assess the Antitumor Efficacy of the MEK Inhibitor Trametinib Alone or in Combination With GSK2141795, an AKT Inhibitor, in Patients With Recurrent or Persistent Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Endometrial Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MDACC Participants

Brief summary: This trial assesses blood and tumor samples for the effect of trametinib with or without uprosertib on biomarkers in patients enrolled on trial GOG02290 with endometrial cancer that is persistent or has come back. Biomarkers found in the blood and tissue may be related to the reaction or response to the study drugs.

Detailed description: PRIMARY OBJECTIVES:

I. To explore the impact of trametinib alone or in combination with uprosertib (GSK2141795) on RAF-MEK-ERK and PI3K pathway signaling.

SECONDARY OBJECTIVES:

I. To examine associations with early changes in functional proteomic biomarkers in tumor biopsies before and after treatment and tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.

II. To examine levels of circulating tumor cells in blood samples before and after treatment and correlate with tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.

III. To examine the bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in paraffin sections from these patients before treatment by proximity ligation assay (PLA) assays.

IV. To quantify exosomes from these patients before and after treatment by enzyme-linked immunosorbent assay (ELISA) assay with CD63 antibody and explore bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in exosomes from these patients before and after treatment by PLA assays.

OUTLINE:

Patients undergo collection of blood at screening, between days 3 and 5, 28, and 56. Patients also undergo collection of tumor biopsy at screening and day 28.

Eligibility criteria: Inclusion Criteria:

* Patients must be enrolled on GOG0229O
* Patients must have tissue available for molecular analysis. This can be tissue obtained at time of current recurrence or archival tissue from primary diagnosis or recurrence
* Patients must have disease lesions that are amenable to pre- and post- treatment biopsy
* Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

* Patients unwilling to undergo a biopsy

Primary outcomes:
measure: Change in biomarker expression
timeFrame: Pre-treatment to post-treatment
Secondary outcomes:
measure: Circulating tumor cells (CTCs) levels
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Shannon Westin
role: PRINCIPAL_INVESTIGATOR
References: