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

NCT02093546 | Completed

• 3 other identifiers: 2013-1029NCI-2018-02663P30CA016672
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in biomarker expression

  Will use descriptive statistics and graphical methods to compare pre-treatment to post-treatment changes in biomarker expression between patients with and without each type of response for each treatment arm and subgroup. Will estimate mean changes from pre-treatment to each post-treatment assessment with 95% confidence intervals. will use a 2-sample t-test to compare treatment arms with respect to the mean change in biomarker expression. Will use a 2-sample Wilcoxon rank sum test to compare treatment arms with respect to the median change in biomarker expression. This testing may also be restricted to specific subgroups (e.g., patients with complete response), depending on the characteristics of patients accrued. Will also use regression methods to model the change in biomarker expression with time and type of response.

  Pre-treatment to post-treatment

Secondary Outcomes (1)

• Circulating tumor cells (CTCs) levels

  Up to 15 years

Study Arms (1)

Ancillary-correlative (Biospecimen collection)

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.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and tumor

Ancillary-correlative (Biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MDACC Participants

You may qualify if:

• 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

You may not qualify if:

• Patients unwilling to undergo a biopsy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shannon Westin

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 21, 2014
• Study Start: August 13, 2004
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (1)