Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
This study is ongoing, but not recruiting participants.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00503581
First received: July 17, 2007
Last updated: December 20, 2011
Last verified: December 2011
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Purpose
RATIONALE: Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.
PURPOSE: This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Precancerous Condition |
Drug: megestrol acetate Procedure: therapeutic conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized, Controlled Phase II Evaluation of Megestrol (Megace®) in Different Dose and Sequence in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Number of patients who have responded to their respective treatment as determined by their re-evaluation biopsy and hysterectomy specimens [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as assessed by CTCAE v4.0 [ Designated as safety issue: Yes ]
- Discordance in diagnosis between the re-evaluation biopsy and the hysterectomy [ Designated as safety issue: No ]
- Relationship between the endometrial thickness and post-treatment diagnosis for those women whom a pre-treatment transvaginal ultrasound is available [ Designated as safety issue: No ]
- PTEN biomarker [ Designated as safety issue: No ]
- Hormone responsivity measures (receptor studies) [ Designated as safety issue: No ]
- Patterns of protein and glycoprotein expression [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Karyometry [ Designated as safety issue: No ]
- Morphology [ Designated as safety issue: No ]
- Histopathology [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Presence or absence of myoinvasion in the hysterectomy specimens [ Designated as safety issue: No ]
- Presence or absence of deep myoinvasion in the hysterectomy specimens [ Designated as safety issue: No ]
| Estimated Enrollment: | 260 |
| Study Start Date: | July 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Regimen 1
Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
|
Drug: megestrol acetate
given orally
Procedure: therapeutic conventional surgery
undergo hysterectomy
|
|
Experimental: Regimen 2
Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
|
Drug: megestrol acetate
given orally
Procedure: therapeutic conventional surgery
undergo hysterectomy
|
|
Active Comparator: Regimen 3 (Closed as of 6/3/2010)
Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.
|
Procedure: therapeutic conventional surgery
undergo hysterectomy
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Inclusion Criteria:
Histologically confirmed atypical endometrial hyperplasia (AEH) or endometrial intraepithelial neoplasia (EIN)
- Diagnosed by dilatation and curettage (D&C), Novak curettage, Vabra aspirate, or Pipelle endometrial biopsy at the enrolling institution within 6 weeks of enrollment
- Must agree to a hysterectomy
Exclusion Criteria:
- Patients with recognized endometrial carcinoma
PATIENT CHARACTERISTICS:
Inclusion Criteria:
- GOG performance status 0-2
- WBC ≥ 3,000/mm^3
- Platelets ≥ 100,000/mm^3
- Granulocytes ≥ 1,500/mm^3
- Creatinine ≤ 2 mg/dL
- Bilirubin ≤ 1.5 x institutional upper limit normal
- SGOT and alkaline phosphatase ≤ 3 x institutional upper limit normal
- Patients of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and must use appropriate nonhormonal contraception while on study
Exclusion Criteria:
- GOG performance status of 3 or 4
- Patients who cannot complete the study
- Patients who are considered inoperable
- Patients with current or prior history of breast cancer
- Patients with invasive malignancies, with the exception of nonmelanoma skin cancer who had (or have) any evidence of the other cancer present within the past 5 years or whose previous cancer treatment contraindicates this protocol therapy
- Patients who are pregnant or lactating
- Patients with a history of thrombophlebitis, thromboembolic phenomena, or cerebrovascular disorders
PRIOR CONCURRENT THERAPY:
Exclusion Criteria:
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503581
Locations
| United States, California | |
| Olive View - UCLA Medical Center Foundation | |
| Sylmar, California, United States, 91342 | |
| United States, Connecticut | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| United States, Indiana | |
| Elkhart Clinic, LLC | |
| Elkhart, Indiana, United States, 46514-2098 | |
| Michiana Hematology-Oncology, PC - Elkhart | |
| Elkhart, Indiana, United States, 46514 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Howard Community Hospital | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Saint Joseph Regional Medical Center | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Michiana Hematology-Oncology, PC - South Bend | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Michiana Hematology Oncology PC - Plymouth | |
| Plymouth, Indiana, United States, 46563 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Michiana Hematology Oncology PC - La Porte | |
| Westville, Indiana, United States, 46391 | |
| United States, Michigan | |
| Lakeside Cancer Specialists, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| Lakeland Regional Cancer Care Center - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65802 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Nevada | |
| Women's Cancer Center - La Canada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| United States, North Carolina | |
| Duke Cancer Institute | |
| Durham, North Carolina, United States, 27710 | |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | |
| Pinehurst, North Carolina, United States, 28374 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Cancer Care Associates - Saint Francis Campus | |
| Tulsa, Oklahoma, United States, 74136-1929 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Study Chair: | Michael W. Method, MD, MPH | Michiana Hematology-Oncology, PC - South Bend |
| Investigator: | Francisco A. R. Garcia, MD, MPH | University of Arizona |
| Investigator: | Cornelia L. Trimble, MD | Sidney Kimmel Comprehensive Cancer Center |
| Investigator: | John P. Curtin, MD | New York University School of Medicine |
| Investigator: | David S. Alberts, MD | University of Arizona |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00503581 History of Changes |
| Other Study ID Numbers: | CDR0000555427, GOG-0224 |
| Study First Received: | July 17, 2007 |
| Last Updated: | December 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
high-grade squamous intraepithelial lesion stage 0 endometrial carcinoma |
Additional relevant MeSH terms:
|
Neoplasms Endometrial Neoplasms Endometrial Hyperplasia Hyperplasia Precancerous Conditions Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Megestrol Megestrol Acetate Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013