SWOG clinical trial number
G0167
A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera
Closed
Phase
Published
Research committees
Gynecologic Cancer
Treatment
Depo-Provera®
Medroxyprogesterone acetate
Eligibility Criteria Expand/Collapse
Atypical endometrial hyperplasia. GOG Performance Status of 0, 1, or 2. Patients with a diagnosis of atypical endometrial hyperplasia, diagnosed by D&C, Novak curettage, Vabra aspirate or Pipelle endometrial biopsy. Part B only: AEH confirmed on expedited review by Johns Hopkins pathologists. Patients must have adequate hematologic, renal and hepatic function: WBC >/= 3,000, platelets >/= 100,000, granulocytes >/= 1,500, creatinine </= 2, bilirubin </= 1.5 x normal, SGOT and alkaline phosphatase </= 3x normal. Part B only: Patients of child-bearing potential must use appropriate non-hormonal contraception while on study. No recognized endometrial carcinoma. No inoperable patients. No other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy. Non-pregnant, non-nursing. No history of thrombophlebitis, thromboembolic phenomena, or cerebrovascular disorders.
Publication Information Expand/Collapse
2006
Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: A Gynecologic Oncology Group Study