This randomized phase II trial is studying how well megestrol works in treating patients
with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of
endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by
blocking the use of estrogen by the abnormal cells.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Inclusion Criteria:
- Patients must have a diagnosis of atypical endometrial hyperplasia (AEH) or
endometrial intraepithelial neoplasia (EIN) diagnosed by dilatation and curettage
(D&C), Novak curettage, Vabra aspirate, or Pipelle endometrial biopsy at the
enrolling institution within 12 weeks of enrollment
- Patients must desire uterine retention for duration of study (18 months or after 3rd
biopsy) if they remain EIN negative (-); patients are allowed to attempt pregnancy
after their initial post-treatment biopsy without it being a major protocol violation
- Patients must have a GOG performance status of 0, 1, or 2
- White blood cell (WBC) >= 3000
- Platelets >= 100,000
- Granulocytes >= 1,500
- Creatinine =< 2
- Bilirubin =< 1. 5 x institutional upper limit normal
- Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x institutional upper limit
normal
- Alkaline phosphatase =< 3 x institutional upper limit normal
- Patients of child-bearing potential must have a negative serum pregnancy test prior
to starting study drug and prior to each biopsy if capable of becoming pregnant (and
at the discretion of the referring physician)
- Patients of childbearing potential must use appropriate non-hormonal contraception
while on study medication
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting
release of personal health information
Exclusion Criteria:
- Patients with a GOG performance status of 3 or 4
- Patients with recognized endometrial carcinoma
- Patients with current or prior history of breast cancer
- Patients with invasive malignancies, with the exception of nonmelanoma skin cancer
who had (or have) any evidence of the other cancer present within the past 5 years or
whose previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are
excluded
- Patients who are pregnant or lactating
- Patients with a history of thrombophlebitis, thromboembolic phenomena, or
cerebrovascular disorders within the past 5 years
- Patients under 18 years of age
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California 90027, United States
Olive View-University of California Los Angeles Medical Center, Sylmar, California 91342, United States
Hartford Hospital, Hartford, Connecticut 06102, United States
Saint Francis Hospital and Medical Center, Hartford, Connecticut 06105, United States
The Hospital of Central Connecticut, New Britain, Connecticut 06050, United States
Memorial University Medical Center, Savannah, Georgia 31404, United States
Saint Anthony's Health, Alton, Illinois 62002, United States
Rush - Copley Medical Center, Aurora, Illinois 60504, United States
Northwestern University, Chicago, Illinois 60611, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois 60435, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois 62864, United States
Carle Clinic-Urbana Main, Urbana, Illinois 61801, United States
Elkhart Clinic, Elkhart, Indiana 46514-2098, United States
Elkhart General Hospital, Elkhart, Indiana 46515, United States
Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana 46514, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202, United States
Community Howard Regional Health, Kokomo, Indiana 46904, United States
IU Health La Porte Hospital, La Porte, Indiana 46350, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana 46360, United States
Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana 46545, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana 46545, United States
Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana 46563, United States
Memorial Hospital of South Bend, South Bend, Indiana 46601, United States
Michiana Hematology Oncology PC-South Bend, South Bend, Indiana 46601, United States
Northern Indiana Cancer Research Consortium CCOP, South Bend, Indiana 46628, United States
South Bend Clinic, South Bend, Indiana 46617, United States
Michiana Hematology Oncology-PC Westville, Westville, Indiana 46391, United States
Gynecologic Oncology of West Michigan PLLC, Grand Rapids, Michigan 49546, United States
Michiana Hematology Oncology PC-Niles, Niles, Michigan 49120, United States
Marie Yeager Cancer Center, Saint Joseph, Michigan 49085, United States
Lakeland Hospital, St. Joseph, Michigan 49085, United States
Saint Francis Medical Center, Cape Girardeau, Missouri 63703, United States
Southeast Missouri Hospital, Cape Girardeau, Missouri 63701, United States
Saint John's Mercy Medical Center, Saint Louis, Missouri 63141, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri 63109, United States
Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri 63141, United States
Mercy Hospital Springfield, Springfield, Missouri 65804, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield, Springfield, Missouri 65804, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada 89169, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York 10461, United States
State University of New York Downstate Medical Center, Brooklyn, New York 11203, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal, Pinehurst, North Carolina 28374, United States
Mount Carmel Health Center West, Columbus, Ohio 43222, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
Cancer Care Associates-Midtown, Tulsa, Oklahoma 74104, United States
Tulsa Cancer Institute, Tulsa, Oklahoma 74146, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia 23298, United States
Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin 53097, United States
Columbia Saint Mary's Water Tower Medical Commons, Milwaukee, Wisconsin 53211, United States