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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00064025 |
Purpose
RATIONALE: Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.
PURPOSE: This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix).
| Condition | Intervention | Phase |
|
Endometrial Cancer |
Drug: medroxyprogesterone Procedure: conventional surgery Procedure: gene expression profiling Procedure: neoadjuvant therapy |
Phase II |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Medroxyprogesterone Medroxyprogesterone 17-acetate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Pilot Investigation Of The Relationship Of Short Term Depo-Provera (Medroxyprogesterone Acetate) Exposure To The Morphologic , Biochemical, And Molecular Changes In Primary Endometroid Adenocarcinoma of the Uterine Corpus |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2003 |
| Estimated Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a pilot, multicenter study.
Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.
A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus
Diagnosis by endometrial curettage or biopsy within the past 8 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Connecticut | |||||
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |||||
| New Britain, Connecticut, United States, 06050 | |||||
| Helen and Harry Gray Cancer Center at Hartford Hospital | |||||
| Hartford, Connecticut, United States, 06102-5037 | |||||
| United States, Illinois | |||||
| University of Illinois Cancer Center | |||||
| Chicago, Illinois, United States, 60612-7243 | |||||
| United States, Iowa | |||||
| Holden Comprehensive Cancer Center at University of Iowa | |||||
| Iowa City, Iowa, United States, 52242-1002 | |||||
| United States, Massachusetts | |||||
| Massachusetts General Hospital | |||||
| Boston, Massachusetts, United States, 02114 | |||||
| United States, Nevada | |||||
| Women's Cancer Center - Lake Mead | |||||
| Las Vegas, Nevada, United States, 89102 | |||||
| United States, Ohio | |||||
| Case Comprehensive Cancer Center | |||||
| Cleveland, Ohio, United States, 44106-5065 | |||||
| Charles M. Barrett Cancer Center at University Hospital | |||||
| Cincinnati, Ohio, United States, 45267 | |||||
| United States, Oregon | |||||
| Williamette Gynecologic Oncology PC | |||||
| Portland, Oregon, United States, 97213 | |||||
| United States, South Carolina | |||||
| Hollings Cancer Center at Medical University of South Carolina | |||||
| Charleston, South Carolina, United States, 29425 | |||||
| Gynecologic Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Richard Zaino, MD | Milton S. Hershey Medical Center |
| Investigator: | Harrison G. Ball, MD | Levine Cancer Center at UMass Medical Center - Memorial Campus |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000306440, GOG-0211 |
| First Received: | July 8, 2003 |
| Last Updated: | September 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00064025 |
| Health Authority: | United States: Federal Government |
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