Baltimore, Maryland 21231

  • Endometrial Cancer

Purpose:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia. PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.


Study summary:

OBJECTIVES: - Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients diagnosed at initial biopsy to have complex atypical hyperplasia. - Compare the histologic response rates in patients with atypical endometrial hyperplasia treated with oral medroxyprogesterone acetate (Provera) vs intramuscular medroxyprogesterone acetate suspension (Depo-Provera) . OUTLINE: This is a randomized, two-part study. - Part A: Patients undergo immediate hysterectomy. - Part B: Patients are randomized to 1 of 2 arms. - Arm I: Patients receive oral medroxyprogesterone acetate (Provera) once daily for 3 months. - Arm II: Patients receive medroxyprogesterone acetate suspension (Depo- Provera) intramuscularly once monthly for 3 months (days 1, 31, and 62). Patients undergo hysterectomy at the end of the third month. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 360 patients for part A and 140 patients (70 per arm) for part B will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed atypical endometrial hyperplasia with recommended treatment with either: - An immediate hysterectomy (Part A) OR - A three-month delay prior to hysterectomy and a randomized choice of treatment with oral medroxyprogesterone acetate (Provera) or medroxyprogesterone acetate suspension (Depo-Provera) during the 3 months (Part B with arms I and II) - Diagnosed by dilation and curettage, Novak curettage, Vabra aspirate or Pipelle endometrial biopsy - No recognized endometrial carcinoma - Must not be considered inoperable PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Granulocyte count at least 1,500/mm^3 Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT no greater than 3 times normal - Alkaline phosphatase no greater than 3 times normal Renal: - Creatinine no greater than 2 times normal Cardiovascular - No prior thrombophlebitis or thromboembolic phenomena - No prior cerebrovascular disorders Other: - No prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the uterine cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - See Disease Characteristics Radiotherapy: - Not specified Surgery: - See Disease Characteristics


Study is Available At:


Original ID:

CDR0000065999


NCT ID:

NCT00003179


Secondary ID:

GOG-0167


Study Acronym:


Brief Title:

Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Primary Purpose: Prevent


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

360


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:John P. Curtin, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:November 1998
Primary Completion Date:February 2006
Primary Completion Type:Actual
Verification Date:July 2006
Last Changed Date:June 7, 2013
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:medroxyprogesterone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Bartels PH, Garcia FA, Trimble CL, Kauderer J, Curtin J, Lim PC, Hess LM, Silverberg S, Zaino RJ, Yozwiak M, Bartels HG, Alberts DS. Karyometry in atypical endometrial hyperplasia: A Gynecologic Oncology Group study. Gynecol Oncol. 2011 Dec 9; [Epub ahead of print]
PMID:22155796
Reference Type:Results Reference
Citation:Trimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ 2nd, Alberts D, Curtin J. Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer. 2006 Feb 15;106(4):812-9.
PMID:16400639

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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