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Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate

Phase 2
18 Years
Open (Enrolling)
Atypical Endometrial Hyperplasia, Endometrial Carcinoma

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Trial Information

Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate

The trial's objectives are to study the efficacy, defined as complete pathologic resolution
of disease, of a standard hormonal regimen with the progestin Megestrol Acetate (MegaceR)
for the treatment of atypical endometrial hyperplasia or well or moderately differentiated
endometrial carcinoma in women desiring conservative medical management of these conditions
in the Women's Cancer Program at the NYU School of Medicine and at the Bellevue Gynecologic
Oncology clinics.

The major endpoint is pathologic complete response (pCR). For the purposes of this study,
patients will be reevaluated for response every 12 weeks until complete response.

Response will be assessed within 4 weeks of completion of 12 weeks of Megace, by endometrial
biopsy or D&C/hysteroscopy. An endometrial biopsy is sufficient to document progressive,
stable disease or partial response. A D&C is necessary to confirm complete response

Patients whose disease has completely responded will discontinue treatment and be encouraged
to pursue fertility. Those not desiring immediate fertility will be placed on low dose ocp's
for at least 6 months.

Patients who have had either a partial response or stable disease will be recounseled and
offered continued medical management or surgical therapy.

Patients whose disease has progressed will be offered definitive surgical management. Those
patients declining surgery will still be followed on study.

Inclusion Criteria:

- Women with a diagnosis of atypical endometrial hyperplasia or G1 or G2 endometrial
carcinoma confirmed by an NYU pathologist desiring medical management will be
eligible. The diagnosis may be obtained either by endometrial biopsy or D&C. If
diagnosis has been made outside of NYU, slides must be available for review.

- Age > = 18 years.

- Life expectancy of greater than 12 months.

- GOG performance status score of 0, 1 or 2

- Patients must have normal organ and marrow function as defined below:

- leukocytes > = 3,000/mcL

- platelets > = 100,000/mcL

- total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) no greater than 2.5 X institutional upper limit of Normal

- glucose < 200 mg/dl

- creatinine within normal institutional limits OR

- creatinine clearance > = 60 mL/min/1.73 m2 for patients with creatinine
levels above institutional normal

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the activity or pharmacokinetics of Megace will be
determined following review of their case by the Principal Investigator.

- The effects of Megace on the developing human fetus at the recommended therapeutic
dose are unknown. For this reason and because Megace is known to be teratogenic,
women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients with a histological diagnosis of clear cell, papillary serous or poorly
differentiated (G3) endometrial carcinoma.

- Patients with cancer have an MRI showing evidence of extrauterine spread or
myometrial invasion.

- Presence of US findings suspicious for ovarian malignancy, unclear endometrial
primary or recurrent endometrial cancer.

- Patients receiving other investigational agents.

- Patients with a history of a previous thrombotic event, known thrombophilic condition
or poorly controlled diabetes.

- Patients with a history of breast cancer or other hormonally responsive malignancy.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study because Megace has the potential for
teratogenic or abortifacient effects. Because there is an unknown but potential risk
for adverse events in nursing infants secondary to treatment of the mother with
Megace, breastfeeding should be discontinued if the mother is treated with Megace.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best pathologic response rates

Outcome Description:

The time is for each patient. Patients will be reevaluated for response every 12 weeks

Outcome Time Frame:

up to 24 months

Safety Issue:


Principal Investigator

Stephanie V Blank, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

February 2015

Related Keywords:

  • Atypical Endometrial Hyperplasia
  • Endometrial Carcinoma
  • Well
  • Moderately
  • Differentiated
  • Carcinoma
  • Endometrial Hyperplasia
  • Hyperplasia
  • Adenoma
  • Endometrial Neoplasms



Bellevue Hospital New York, New York  10016
NYU Cancer Center New York, New York  10016