Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00503581
First received: July 17, 2007
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. 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.


Condition Intervention Phase
High Grade Squamous Intraepithelial Neoplasia
Stage 0 Uterine Corpus Cancer
Procedure: Biopsy
Other: Laboratory Biomarker Analysis
Drug: Megestrol Acetate
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Procedure: Therapeutic Conventional Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Evaluation of Continuous Progestin Therapy vs. Sequential Progestin Therapy in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Patients That Desire Uterine Preservation

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Number of patients who experience a response as determined by a central blinded review of the three post treatment endometrial [ Time Frame: Up to 12 months after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quality of life (QOL) evaluated using the Hospital Anxiety and Depression Scale (HADS) and the two items on bleeding and weight gain [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: July 2007
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1 (megestrol acetate, surgery)
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.
Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY
  • Bx
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Megestrol Acetate
given orally
Other Names:
  • 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
  • 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
  • 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone
  • 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
  • BDH 1298
  • BDH-1298
  • Maygace
  • Megace
  • Megestat
  • Megestil
  • MEGESTROL ACETATE
  • Niagestin
  • Ovaban
  • Pallace
  • SC-10363
Other: Pharmacological Study
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Procedure: Therapeutic Conventional Surgery
undergo hysterectomy
Experimental: Regimen 2 (megestrol acetate, surgery)
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.
Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY
  • Bx
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Megestrol Acetate
given orally
Other Names:
  • 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
  • 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
  • 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone
  • 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
  • BDH 1298
  • BDH-1298
  • Maygace
  • Megace
  • Megestat
  • Megestil
  • MEGESTROL ACETATE
  • Niagestin
  • Ovaban
  • Pallace
  • SC-10363
Other: Pharmacological Study
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Procedure: Therapeutic Conventional Surgery
undergo hysterectomy
Active Comparator: Regimen 3 (surgery/biopsy)
(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: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY
  • Bx
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
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

Inclusion Criteria:

  • Patients must have a diagnosis of 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 12 weeks of enrollment
  • Patients must desire uterine retention for duration of study (18 months or after 3rd biopsy) if they remain EIN negative (-); patients are allowed to attempt pregnancy after their initial post-treatment biopsy without it being a major protocol violation
  • Patients must have a GOG performance status of 0, 1, or 2
  • White blood cell (WBC) >= 3000
  • Platelets >= 100,000
  • Granulocytes >= 1,500
  • Creatinine =< 2
  • Bilirubin =< 1.5 x institutional upper limit normal
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x institutional upper limit normal
  • Alkaline phosphatase =< 3 x institutional upper limit normal
  • Patients of child-bearing potential must have a negative serum pregnancy test prior to starting study drug and prior to each biopsy if capable of becoming pregnant (and at the discretion of the referring physician)
  • Patients of childbearing potential must use appropriate non-hormonal contraception while on study medication
  • Patients who have met the pre-entry requirements
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

  • Patients with a GOG performance status of 3 or 4
  • Patients with recognized endometrial carcinoma
  • 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 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
  • Patients who are pregnant or lactating
  • Patients with a history of thrombophlebitis, thromboembolic phenomena, or cerebrovascular disorders within the past 5 years
  • Patients under 18 years of age
  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: NCT00503581

  Show 50 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Michael Method Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00503581     History of Changes
Other Study ID Numbers: GOG-0224, NCI-2009-00594, GOG-0224, CDR0000555427, GOG-0224, GOG-0224, GOG-0224, U10CA101165
Study First Received: July 17, 2007
Last Updated: May 27, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 30, 2015