Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate
Condition: Atypical Endometrial Hyperplasia; Endometrial Carcinoma
MeSH terms: Carcinoma; Endometrial Neoplasms; Endometrial Hyperplasia; Hyperplasia
Intervention: Megestrol Acetate
Intervention MeSH terms: Megestrol; Megestrol Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Well; Moderately; Differentiated

Summary:

      The purpose of this trial is to study the efficacy, toxicity, and tolerability of a standard
      hormonal regimen of Megestrol Acetate (Megace) in the treatment of Atypical Endometrial
      Hyperplasia or well to moderately differentiated endometrial carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with a diagnosis of atypical endometrial hyperplasia or G1 or G2 endometrial
             carcinoma confirmed by an New York University (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.

          -  Gynecologic Oncology Group (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 document.

        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.