Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Megestrol; Megestrol Acetate; Progestins

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