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.
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) who are planned and appropriate for primary surgical treatment to include removal of the uterine corpus via any surgical modality. The patient must be considered a suitable surgical candidate
Patients with any non-endometrioid histology (such as serous, clear cell, or carcinosarcoma or mixed)
Patients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established. Estrogen therapy alone is allowed
Patients with ECOG performance status of 4
Patients with history of deep venous thrombosis or pulmonary embolism within the past 2 years or ongoing thromboembolic disorders
Parallel
Biopsy Procedure
Procedure/SurgeryUndergo biopsy
Curettage Procedure
Procedure/SurgeryUndergo curettage
Hysterectomy
Procedure/SurgeryUndergo hysterectomy
Megestrol Acetate
DrugGiven PO
Progesterone Only Hormone Replacement Therapy
DrugGiven PO
Tissue response to progestin therapy
Will be determined by a change in the percentage in the expression of the proliferative marker Ki-67 comparing the pretreatment diagnostic biopsy to the posttreatment hysterectomy specimen. Immunohistochemical evaluation of Ki-67 protein expression will be determined as a continuous variable using the percent of cells staining positive in the nucleus
Click on the lead sponsor to view all of their trials.
New Mexico Cancer Research Alliance
Lead sponsor
University of New Mexico Cancer Center
Collaborator
National Cancer Institute (NCI)
Collaborator
