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/Nonmalignant Condition	Drug: megestrol acetate Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized
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 v3.0 [ 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 ]
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:	380
Study Start Date:	July 2007

Arms	Assigned Interventions
Regimen 1: Experimental Patients receive oral megestrol twice daily every day for 12 weeks. Approximately 6 weeks after treatment starts, clinical blood tests will be obtained and research serum and plasma collected. Twelve weeks will constitute one course of treatment and a pill count should be performed at the completion of the treatment course to determine compliance. After progestin therapy the patient will have an induced withdrawal bleed. Patients in this arm will undergo a re-evaluation biopsy and hysterectomy a minimum of 2 weeks and a maximum of 8 weeks after completing the megestrol treatment.	Drug: megestrol acetate given orally Procedure: conventional surgery undergo hysterectomy
Regimen 2: Experimental Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for 2 weeks. This cycle will be repeated for a total of 12 weeks. Approximately 6 weeks after treatment starts, clinical blood tests will be obtained and research serum and plasma collected. Twelve weeks will constitute one course of treatment and a pill count should be performed at the completion of the treatment course to determine compliance. After progestin therapy the patient will have an induced withdrawal bleed. Patients in this arm will undergo a re-evaluation biopsy and hysterectomy a minimum of 2 weeks and a maximum of 8 weeks after the megestrol treatment.	Drug: megestrol acetate given orally Procedure: conventional surgery undergo hysterectomy
Regimen 3: Active Comparator 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: conventional surgery undergo hysterectomy

Show Detailed Description

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

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Locations

United States, California
Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
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
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
United States, Indiana
South Bend Clinic
South Bend, Indiana, United States, 46617
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Michigan
Gynecologic Oncology of West Michigan
Grand Rapids, Michigan, United States, 49546
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
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
United States, Oklahoma
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States, 74136-1929
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Wisconsin
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211

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:	Gynecologic Oncology Group ( Philip J. DiSaia )
Study ID Numbers:	CDR0000555427, GOG-0224
Study First Received:	July 17, 2007
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00503581 History of Changes
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:

Precancerous Conditions
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Uterine Neoplasms

Contraceptives, Oral, Synthetic
Appetite Stimulants
Antineoplastic Agents, Hormonal
Genital Neoplasms, Female
Uterine Diseases
Central Nervous System Stimulants
Megestrol
Pharmacologic Actions
Neoplasms
Hyperplasia
Central Nervous System Agents
Megestrol Acetate
Endometrial Hyperplasia

ClinicalTrials.gov processed this record on November 30, 2009