Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
A Randomized Phase II Evaluation of Continuous Progestin Therapy vs. Sequential Progestin Therapy in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Patients That Desire Uterine Preservation
4 other identifiers
interventional
9
1 country
50
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedResults Posted
Study results publicly available
October 14, 2020
CompletedNovember 3, 2020
October 1, 2020
5 years
July 17, 2007
August 11, 2020
October 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients Who Experience a Response as Determined by a Central Blinded Review of the Three Post Treatment Endometrial
Treated and eligible participants. This study had 0 participants that completed treatment, therefore no analysis was done. Study closed prior to completion. Central blinded review was not performed for any participants in the study.
Up to 12 months after completion of treatment
Secondary Outcomes (1)
Change in Quality of Life (QOL) Evaluated Using the Hospital Anxiety and Depression Scale (HADS) and the Two Items on Bleeding and Weight Gain
Baseline to up to 12 months
Study Arms (3)
Regimen 1 (megestrol acetate, surgery)
EXPERIMENTALPatients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
Regimen 2 (megestrol acetate, surgery)
EXPERIMENTALPatients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
Regimen 3 (surgery/biopsy)
ACTIVE COMPARATOR(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.
Interventions
Undergo biopsy
Correlative studies
given orally
Correlative studies
Ancillary studies
undergo hysterectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (50)
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
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, 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
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, 46628, 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
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, 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
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon for James Kauderer
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Method
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 19, 2007
Study Start
July 1, 2007
Primary Completion
July 1, 2012
Last Updated
November 3, 2020
Results First Posted
October 14, 2020
Record last verified: 2020-10