Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: medroxyprogesterone

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003179

CDR0000065999

GOG-0167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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