Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
This study has been completed.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00064025
First received: July 8, 2003
Last updated: September 16, 2010
Last verified: September 2008
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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 Genetic: microarray analysis Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Histologic response [ Designated as safety issue: No ]
- Steroid receptor status as assessed by immunohistochemistry (IHC) [ Designated as safety issue: No ]
- Growth and apoptosis as assessed by IHC [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2003 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.
- Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.
- Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response, steroid receptor status, immunohistochemical measures of growth and apoptosis, and gene expression profiles in patients treated with this drug.
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 |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus
- All histologic grades and stages eligible
Diagnosis by endometrial curettage or biopsy within the past 8 weeks
- Must have the initial tissue block or 16 unstained sections of 5 micron thickness available
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No history of thrombophlebitis or thromboembolic disorders
Other
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
- No concurrent aminoglutethimide
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
- No prior cancer treatment that would preclude study therapy
- No concurrent bosentan
- No concurrent rifampin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064025
Locations
| United States, Connecticut | |
| Helen and Harry Gray Cancer Center at Hartford Hospital | |
| Hartford, Connecticut, United States, 06102-5037 | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |
| New Britain, Connecticut, United States, 06050 | |
| 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 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| 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 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| 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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00064025 History of Changes |
| Other Study ID Numbers: | CDR0000306440, GOG-0211 |
| Study First Received: | July 8, 2003 |
| Last Updated: | September 16, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent endometrial carcinoma stage I endometrial carcinoma stage II endometrial carcinoma stage III endometrial carcinoma |
stage IV endometrial carcinoma endometrial adenoacanthoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Endometrial Neoplasms Carcinoma, Endometrioid Adenoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases |
Genital Diseases, Female Ovarian Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Medroxyprogesterone Medroxyprogesterone Acetate Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013