Evaluating Promising Progestins in Endometrial Cancer Through a Rotating Umbrella Surgical Window Trial - The PRO-WINDOW TRIAL for Endometrial Cancer
New Mexico Cancer Research Alliance
Summary
This phase II trial tests compares the effect of progestins, megestrol acetate to micronized progesterone, in treating patients with endometrial cancer and precancers of the uterus (atypical endometrial hyperplasia) before surgery. Progestins, similar to the natural hormone progesterone, are approved drugs used in birth control and hormone replacement pills, and some can treat uterine endometrial cancers. In the initial comparison of this rotating umbrella trial, megestrol acetate, a progestin, will be compared to micronized progesterone, a form of natural progesterone that is a hormone produced by body normally. Hormone therapy using megestrol acetate and micronized progesterone may be effective in treating patients with endometrial cancer or atypical endometrial hyperplasia before surgery, and understanding the tissue effects of each agent on the malignant endometrium will uncover novel mechanistic and biomarker data to understand how best to advanced hormone therapy for endometrial cancer.
Description
PRIMARY OBJECTIVES: I. Perform an adaptive, master protocol, surgical window of opportunity rotating umbrella trial to assess the effectiveness of progestins in tissues from women with newly diagnosed endometrial cancer or atypical endometrial hyperplasia. II. Establish biomarkers and molecular signatures of progestin efficacy in patients with endometrial cancer. OUTLINE: Patients are randomized to 1 of 2 arms in the initial comparison. ARM I: Patients undergo biopsy or curettage and then receive megestrol acetate orally (PO) twice daily (BID) 21-24 days prior to standard of care (SOC) hys…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks prior to registration. Pathology reports should document adequate tissue from the biopsy and slides should be reasonable determined to be obtainable by the study team for study use * History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1) * Age ≥ 18 * The trial is open only to women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) w…
Interventions
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureCurettage Procedure
Undergo curettage
- ProcedureHysterectomy
Undergo hysterectomy
- DrugMegestrol Acetate
Given PO
- DrugProgesterone Only Hormone Replacement Therapy
Given PO
Locations (4)
- University of Iowa/Holden Comprehensive Cancer CenterIowa City, Iowa
- University of New Mexico Cancer CenterAlbuquerque, New Mexico
- University of Utah Sugarhouse Health CenterSalt Lake City, Utah
- University of Virginia Cancer CenterCharlottesville, Virginia