Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a single centre, single arm, open label, preoperative window of opportunity study. Grade 2 endometrioid endometrial carcinoma patients awaiting surgery will be prospectively recruited to receive a pre-operative progestin therapy course. Therapy response will be histologically evaluated and correlated with clinical and molecular data by comparison of responders vs. non-responders pre- and post-treatment tumor samples.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: Ontario Institute for Cancer Research
• Treatments: Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

• Adult female patient 18 years of age or older.

• Confirmed diagnosis of FIGO grade 2 endometrioid endometrial cancer on preoperative endometrial biopsy read by a pathologist with a subspecialty in gynecologic pathology.

• Stage 1 endometrioid endometrial cancer on preoperative endometrial biopsy.

• P53 wild type immunohistochemistry on preoperative endometrial biopsy.

• Patients eligible for primary staging surgery for definitive treatment for their cancer.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Required Initial Laboratory Values obtained within 3 days of enrolment following standard of care protocols: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet Count ≥ 100,000/mm3; eGFR ≥ 60 mL/min/1.73m2; Total Bilirubin ≤ 1.5 x upper limit of normal (ULN); AST / ALT ≤ 2.5 x upper limit of normal (ULN).

• Informed consent for this study is obtained and signed by the participant or have an acceptable Substitute Decision Maker (SDM) capable of signing the informed consent form on behalf of the participant.

Exclusion Criteria:

• Patients cannot be receiving systemic or hormonal therapy for treatment of the endometrial cancer.

• Prior radiation therapy for treatment of the endometrial cancer is not allowed.

• Stage 2 or 3 endometrioid endometrial cancer on preoperative endometrial biopsy.

• Abnormal p53 immunohistochemistry on preoperative endometrial biopsy.

• History of an allergic reaction to medroxyprogesterone acetate.

• History of venous thromboembolic event (including previous deep vein thrombosis or pulmonary embolism).

• Family history of venous thromboembolic event.

• Have a >20 pack-year smoking history.

• Patients unwilling or unable to follow the study protocol schedule.