Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
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| ClinicalTrials.gov Identifier: NCT00003179 |
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Recruitment Status :
Terminated
First Posted : January 27, 2003
Last Update Posted : June 10, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Endometrial Cancer | Drug: medroxyprogesterone | Phase 2 |
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.
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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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 360 participants |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | November 1998 |
| Actual Primary Completion Date : | February 2006 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003179
Show 31 study locations
| Study Chair: | John P. Curtin, MD | Memorial Sloan Kettering Cancer Center | |
| OverallOfficial: | George L. Mutter, MD | Dana-Farber/Brigham and Women's Cancer Center | |
| OverallOfficial: | Francisco A. R. Garcia, MD, MPH | University of Arizona | |
| OverallOfficial: | Richard Zaino, MD | Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT00003179 |
| Other Study ID Numbers: |
CDR0000065999 GOG-0167 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 10, 2013 |
| Last Verified: | July 2006 |
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endometrial cancer |
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Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Medroxyprogesterone Acetate Medroxyprogesterone Contraceptives, Oral, Hormonal |
Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptives, Oral, Synthetic Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents |