Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00483327
First received: June 5, 2007
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The purpose of this trial is to study the efficacy, toxicity, and tolerability of a standard hormonal regimen of Megace in the treatment of Atypical Endometrial Hyperplasia or well to moderately differentiated endometrial carcinoma.


Condition Intervention Phase
Atypical Endometrial Hyperplasia
Endometrial Carcinoma
Drug: Megestrol Acetate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Best pathologic response rates [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    The time is for each patient. Patients will be reevaluated for response every 12 weeks


Secondary Outcome Measures:
  • toxicity and tolerability duration of response [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up.

  • rate of pregnancy [ Time Frame: up to 3 years after the treament for each patient ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Megestrol Acetate
80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks
Drug: Megestrol Acetate
Other Name: Megace

Detailed Description:

The trial's objectives are to study the efficacy, defined as complete pathologic resolution of disease, of a standard hormonal regimen with the progestin Megestrol Acetate (MegaceR) for the treatment of atypical endometrial hyperplasia or well or moderately differentiated endometrial carcinoma in women desiring conservative medical management of these conditions in the Women's Cancer Program at the NYU School of Medicine and at the Bellevue Gynecologic Oncology clinics.

The major endpoint is pathologic complete response (pCR). For the purposes of this study, patients will be reevaluated for response every 12 weeks until complete response.

Response will be assessed within 4 weeks of completion of 12 weeks of Megace, by endometrial biopsy or D&C/hysteroscopy. An endometrial biopsy is sufficient to document progressive, stable disease or partial response. A D&C is necessary to confirm complete response

Patients whose disease has completely responded will discontinue treatment and be encouraged to pursue fertility. Those not desiring immediate fertility will be placed on low dose ocp's for at least 6 months.

Patients who have had either a partial response or stable disease will be recounseled and offered continued medical management or surgical therapy.

Patients whose disease has progressed will be offered definitive surgical management. Those patients declining surgery will still be followed on study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with a diagnosis of atypical endometrial hyperplasia or G1 or G2 endometrial carcinoma confirmed by an NYU pathologist desiring medical management will be eligible. The diagnosis may be obtained either by endometrial biopsy or D&C. If diagnosis has been made outside of NYU, slides must be available for review.
  • Age > = 18 years.
  • Life expectancy of greater than 12 months.
  • GOG performance status score of 0, 1 or 2
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes > = 3,000/mcL
    • platelets > = 100,000/mcL
    • total bilirubin within normal institutional limits
    • AST(SGOT)/ALT(SGPT) no greater than 2.5 X institutional upper limit of Normal
    • glucose < 200 mg/dl
    • creatinine within normal institutional limits OR
    • creatinine clearance > = 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of Megace will be determined following review of their case by the Principal Investigator.
  • The effects of Megace on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Megace is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients with a histological diagnosis of clear cell, papillary serous or poorly differentiated (G3) endometrial carcinoma.
  • Patients with cancer have an MRI showing evidence of extrauterine spread or myometrial invasion.
  • Presence of US findings suspicious for ovarian malignancy, unclear endometrial primary or recurrent endometrial cancer.
  • Patients receiving other investigational agents.
  • Patients with a history of a previous thrombotic event, known thrombophilic condition or poorly controlled diabetes.
  • Patients with a history of breast cancer or other hormonally responsive malignancy.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because Megace has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Megace, breastfeeding should be discontinued if the mother is treated with Megace.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483327

Locations
United States, New York
NYU Cancer Center
New York, New York, United States, 10016
Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Stephanie V Blank, M.D. New York University
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00483327     History of Changes
Other Study ID Numbers: 06-685
Study First Received: June 5, 2007
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Well
Moderately
Differentiated

Additional relevant MeSH terms:
Carcinoma
Hyperplasia
Endometrial Neoplasms
Endometrial Hyperplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Megestrol Acetate
Megestrol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 16, 2014