Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
NCT ID: NCT00503581
Last Updated: 2020-11-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2007-07-31
Brief Summary
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Detailed Description
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I. To determine the frequency of complete remission by a central pathology review panel in diagnosed endometrial intraepithelial neoplasia (EIN) patients treated for 24 weeks with oral continuous versus interrupted progestin therapy.
SECONDARY OBJECTIVES:
I. To evaluate whether quality of life is superior in patients who take continuous megestrol versus sequential megestrol by evaluating mood, concerns about weight changes and bleeding.
TERTIARY:
I. To assess the expression levels of PTEN using immunohistochemistry and to explore the association of PTEN expression levels with patient response to treatment.
II. To assess the expression levels of the hormone receptors ER and PR using immunohistochemistry and to explore the association of ER/PR expression levels with patient response to treatment.
III. To assess histomorphometry and karyometry characteristics of the pre-treatment biopsy in this patient population.
IV. To identify patterns of protein and glycoprotein expression associated with invasive cancer in serum specimens obtained from patients with a diagnosis of atypical endometrial hyperplasia (AEH) or EIN.
V. To assess differences in plasma concentrations of megestrol acetate HPLC in this patient population.
VI. To assess patient compliance to their treatment regimen using HPLC.
OUTLINE: Patients are stratified according to the collection method of the initial/intake biopsy (dilatation and curettage vs all other methods). Patients are randomized to 1 of the following treatment regimens:
REGIMEN 1: Patients 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: Patients 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: (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. Patients undergo biopsy and blood sample collection periodically for immunological and pharmacodynamic studies. Samples are analyzed for presence or absence of myoinvasion or deep myoinvasion in hysterectomy specimens, hormone receptivity status, and to compare PTEN status against treatment via karyometry or morphometry, expression of VEGF and tenascin-C (TN-C) via ELISA, presence of TN-C fragmentation via western immunoblots, additional biomarkers via proteomic analysis, protein and glycoprotein expression patterns via electrophoresis and image analysis, and plasma megestrol concentrations via high-performance liquid chromatography (HPLC). Patients complete the Hospital Anxiety and Depression Scale (HADS) and two items on bleeding and weight gain at baseline and periodically during study. A Treatment Decision Assessment is completed at baseline, and for patients withdrawing from the study, a Study Withdraw Assessment is also completed. There will be no additional follow-up on this study after the patient's hysterectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regimen 1 (megestrol acetate, surgery)
Patients 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.
Biopsy
Undergo biopsy
Laboratory Biomarker Analysis
Correlative studies
Megestrol Acetate
given orally
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Therapeutic Conventional Surgery
undergo hysterectomy
Regimen 2 (megestrol acetate, surgery)
Patients 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.
Biopsy
Undergo biopsy
Laboratory Biomarker Analysis
Correlative studies
Megestrol Acetate
given orally
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Therapeutic Conventional Surgery
undergo hysterectomy
Regimen 3 (surgery/biopsy)
(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.
Biopsy
Undergo biopsy
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Therapeutic Conventional Surgery
undergo hysterectomy
Interventions
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Biopsy
Undergo biopsy
Laboratory Biomarker Analysis
Correlative studies
Megestrol Acetate
given orally
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Therapeutic Conventional Surgery
undergo hysterectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Michael Method
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Memorial University Medical Center
Savannah, Georgia, United States
Saint Anthony's Health
Alton, Illinois, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Carle Clinic-Urbana Main
Urbana, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, United States
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, United States
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Saint John's Mercy Medical Center
St Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
State University of New York Downstate Medical Center
Brooklyn, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2009-00594
Identifier Type: REGISTRY
Identifier Source: secondary_id
GOG-0224
Identifier Type: -
Identifier Source: secondary_id
CDR0000555427
Identifier Type: -
Identifier Source: secondary_id
GOG-0224
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0224
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0224
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0224
Identifier Type: -
Identifier Source: org_study_id