- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00483327
Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate
Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate
Study Overview
Status
Intervention / Treatment
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 Megace 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 dilation and curettage (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 oral contraceptive pills 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10016
- Bellevue Hospital
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New York, New York, United States, 10016
- NYU Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Megestrol Acetate
80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Pathologic Responses
Time Frame: up to 24 months
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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.
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up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity and Tolerability
Time Frame: up to 36 months
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Patients with adverse events (AEs) which were possibly, probably, or definitely related to the treatment.
AEs were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) 3.
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up to 36 months
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Duration of Response
Time Frame: up to 4 years
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For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up.
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up to 4 years
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Number of Women Who Became Pregnant
Time Frame: up to 3 years after the treatment for each patient
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up to 3 years after the treatment for each patient
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephanie V Blank, M.D., New York University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Carcinoma
- Hyperplasia
- Endometrial Hyperplasia
- Endometrial Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Appetite Stimulants
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- 06-685
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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