Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
Condition: High Grade Squamous Intraepithelial Neoplasia; Stage 0 Uterine Corpus Cancer
MeSH terms: Neoplasms; Carcinoma in Situ; Endometrial Hyperplasia; Hyperplasia
Intervention: Biopsy; Laboratory Biomarker Analysis; Megestrol Acetate; Pharmacological Study; Quality-of-Life Assessment; Therapeutic Conventional Surgery
Intervention description: Undergo biopsy; Correlative studies; given orally; Correlative studies; Ancillary studies; undergo hysterectomy
Intervention MeSH terms: Megestrol; Megestrol Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of 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 12 weeks of enrollment

          -  Patients must desire uterine retention for duration of study (18 months or after 3rd
             biopsy) if they remain EIN negative (-); patients are allowed to attempt pregnancy
             after their initial post-treatment biopsy without it being a major protocol violation

          -  Patients must have a GOG performance status of 0, 1, or 2

          -  White blood cell (WBC) >= 3000

          -  Platelets >= 100,000

          -  Granulocytes >= 1,500

          -  Creatinine =< 2

          -  Bilirubin =< 1.5 x institutional upper limit normal

          -  Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x institutional upper limit normal

          -  Alkaline phosphatase =< 3 x institutional upper limit normal

          -  Patients of child-bearing potential must have a negative serum pregnancy test prior to
             starting study drug and prior to each biopsy if capable of becoming pregnant (and at
             the discretion of the referring physician)

          -  Patients of childbearing potential must use appropriate non-hormonal contraception
             while on study medication

          -  Patients who have met the pre-entry requirements

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

        Exclusion Criteria:

          -  Patients with a GOG performance status of 3 or 4

          -  Patients with recognized endometrial carcinoma

          -  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 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

          -  Patients who are pregnant or lactating

          -  Patients with a history of thrombophlebitis, thromboembolic phenomena, or
             cerebrovascular disorders within the past 5 years

          -  Patients under 18 years of age