Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

NCT00483327 | Completed Phase 2 Results DMC

• 1 other identifier: 06-685
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atypical Endometrial Hyperplasia; Endometrial Carcinoma

Keywords

Well; Moderately; Differentiated

Outcome Measures

Primary Outcomes (1)

• Best Pathologic Responses

  Patients are evaluated every 12 weeks while on treatment. The response is evaluated by endometrial biopsy or dilation and curettage (D\&C)/hysteroscopy. Complete response (CR) is defined as endometrial sampling is read as normal or proliferative endometrium. Partial response (PR) is defined as the biopsy sample has changed on the endometrial evaluation scale by at least one level towards normal. Stable disease (SD) is defined as no change in pathology between the index and follow-up sample. Progressive disease (PD) is defined the follow-up sample has changed towards neoplasia on the endometrial evaluation scale by at least one level or imaging is concerning for myometrial invasion or extrauterine disease such that conservative management is no longer medically appropriate.

  up to 24 months

Secondary Outcomes (3)

• Toxicity and Tolerability

  up to 36 months

• Duration of Response

  up to 4 years

• Number of Women Who Became Pregnant

  up to 3 years after the treatment for each patient

Study Arms (1)

Megestrol Acetate

EXPERIMENTAL

80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.

Drug: Megestrol Acetate

Interventions

Megestrol Acetate DRUG

Also known as: Megace

Megestrol Acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a diagnosis of atypical endometrial hyperplasia or G1 or G2 endometrial carcinoma confirmed by an New York University (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.
• Gynecologic Oncology Group (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Stephanie Blank, MD
• Organization: Perlmutter Cancer Center at NYU Langone

stephanie.blank@nyumc.org

212-731-5705

Study Officials

• Stephanie V Blank, M.D.

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 7, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 4, 2018
• Results First Posted: July 1, 2016

Record last verified: 2018-03

Locations

US (2)