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

Sponsors and Collaborators:	Gynecologic Oncology Group 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

MedlinePlus related topics: Cancer Hysterectomy

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

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

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

Show 33 Study Locations

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

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Precancerous Conditions
Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female
Genital Neoplasms, Female
Uterine Diseases
Central Nervous System Stimulants
Urogenital Neoplasms
Endometrial Cancer

Megestrol
Carcinoma
Genital Diseases, Female
Endometrial Neoplasms
Hyperplasia
Uterine Neoplasms
Appetite Stimulants
Megestrol Acetate
Endometrial Hyperplasia

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 May 07, 2009