Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003179

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.

Condition	Intervention	Phase
Endometrial Cancer	Drug: medroxyprogesterone	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Medroxyprogesterone 17-acetate Medroxyprogesterone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	360
Study Start Date:	November 1998

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003179

Show 31 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	John P. Curtin, MD	Memorial Sloan-Kettering Cancer Center
Investigator:	George L. Mutter, MD	Dana-Farber/Brigham and Women's Cancer Center
Investigator:	Francisco A. R. Garcia, MD, MPH	University of Arizona
Investigator:	Richard Zaino, MD	Milton S. Hershey Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000065999, GOG-0167
Study First Received:	November 1, 1999
Last Updated:	August 1, 2009
ClinicalTrials.gov Identifier:	NCT00003179 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

endometrial cancer

Additional relevant MeSH terms:

Medroxyprogesterone 17-Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Reproductive Control Agents

Contraceptive Agents, Male
Pharmacologic Actions
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Uterine Neoplasms
Contraceptives, Oral, Synthetic
Medroxyprogesterone
Endometrial Hyperplasia

ClinicalTrials.gov processed this record on November 22, 2009