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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 |
| 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 | |
| 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
| Study ID Numbers: | CDR0000306440, GOG-0211 |
| Study First Received: | July 8, 2003 |
| Last Updated: | September 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00064025 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Ovarian cancer Medroxyprogesterone 17-Acetate Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Carcinoma, Endometrioid Recurrence |
Carcinoma Genital Diseases, Female Endometrial Neoplasms Uterine Neoplasms Medroxyprogesterone Endocrinopathy Endometrial cancer Adenocarcinoma Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents |
Contraceptive Agents, Male Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Contraceptives, Oral, Synthetic |
