Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00503581

Purpose

RATIONALE: 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.

PURPOSE: This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia.

Condition	Intervention	Phase
Endometrial Cancer Precancerous Condition	Drug: megestrol acetate Procedure: therapeutic conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Randomized, Controlled Phase II Evaluation of Megestrol (Megace®) in Different Dose and Sequence in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hysterectomy

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Number of patients who have responded to their respective treatment as determined by their re-evaluation biopsy and hysterectomy specimens [ Designated as safety issue: No ]
Frequency and severity of adverse effects as assessed by CTCAE v4.0 [ Designated as safety issue: Yes ]
Discordance in diagnosis between the re-evaluation biopsy and the hysterectomy [ Designated as safety issue: No ]
Relationship between the endometrial thickness and post-treatment diagnosis for those women whom a pre-treatment transvaginal ultrasound is available [ Designated as safety issue: No ]
PTEN biomarker [ Designated as safety issue: No ]
Hormone responsivity measures (receptor studies) [ Designated as safety issue: No ]
Patterns of protein and glycoprotein expression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Karyometry [ Designated as safety issue: No ]
Morphology [ Designated as safety issue: No ]
Histopathology [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Presence or absence of myoinvasion in the hysterectomy specimens [ Designated as safety issue: No ]
Presence or absence of deep myoinvasion in the hysterectomy specimens [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	July 2007

Arms	Assigned Interventions
Experimental: 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.	Drug: megestrol acetate given orally Procedure: therapeutic conventional surgery undergo hysterectomy
Experimental: 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.	Drug: megestrol acetate given orally Procedure: therapeutic conventional surgery undergo hysterectomy
Active Comparator: 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.	Procedure: therapeutic conventional surgery undergo hysterectomy

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Inclusion Criteria:
- Histologically confirmed 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 6 weeks of enrollment
  - Must agree to a hysterectomy
Exclusion Criteria:
- Patients with recognized endometrial carcinoma

PATIENT CHARACTERISTICS:

Inclusion Criteria:
- GOG performance status 0-2
- WBC ≥ 3,000/mm^3
- Platelets ≥ 100,000/mm^3
- Granulocytes ≥ 1,500/mm^3
- Creatinine ≤ 2 mg/dL
- Bilirubin ≤ 1.5 x institutional upper limit normal
- SGOT and alkaline phosphatase ≤ 3 x institutional upper limit normal
- Patients of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and must use appropriate nonhormonal contraception while on study
Exclusion Criteria:
- GOG performance status of 3 or 4
- Patients who cannot complete the study
- Patients who are considered inoperable
- 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 are pregnant or lactating
- Patients with a history of thrombophlebitis, thromboembolic phenomena, or cerebrovascular disorders

PRIOR CONCURRENT THERAPY:

Exclusion Criteria:
- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503581

Locations

United States, California
Olive View - UCLA Medical Center Foundation
Sylmar, California, United States, 91342
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Indiana
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Michigan
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center - La Canada
Las Vegas, Nevada, United States, 89169
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States, 74136-1929
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Michael W. Method, MD, MPH	Michiana Hematology-Oncology, PC - South Bend
Investigator:	Francisco A. R. Garcia, MD, MPH	University of Arizona
Investigator:	Cornelia L. Trimble, MD	Sidney Kimmel Comprehensive Cancer Center
Investigator:	John P. Curtin, MD	New York University School of Medicine
Investigator:	David S. Alberts, MD	University of Arizona

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00503581 History of Changes
Other Study ID Numbers:	CDR0000555427, GOG-0224
Study First Received:	July 17, 2007
Last Updated:	December 20, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

high-grade squamous intraepithelial lesion
stage 0 endometrial carcinoma

Additional relevant MeSH terms:

Endometrial Neoplasms
Disease
Endometrial Hyperplasia
Hyperplasia
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Megestrol Acetate

Megestrol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 12, 2012