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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00071929 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: oxaliplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma |
| Study Start Date: | November 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 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 endometrial carcinoma that is refractory to curative therapy or established treatment
Measurable disease by physical examination or medical imaging
Must have received 1 prior cytotoxic therapy regimen
1 additional noncytotoxic regimen allowed
Biologic or cytostatic agents include, but are not limited to:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Arizona | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, California | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Connecticut | |
| New Britain General Hospital | |
| New Britain, Connecticut, United States, 06052 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62794-9640 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Michigan | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| United States, New York | |
| Long Island Cancer Center at Stony Brook University Hospital | |
| Stony Brook, New York, United States, 11790-7775 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44124 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| United States, Oklahoma | |
| University of Oklahoma College of Medicine | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001-3788 | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213-3180 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Tennessee | |
| Southeast Gynecologic Oncology Associates | |
| Knoxville, Tennessee, United States, 37917 | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-2516 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Study Chair: | Paula M. Fracasso, MD, PhD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
More Information
| Study ID Numbers: | CDR0000068235, GOG-0129K |
| Study First Received: | November 4, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00071929 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma |
|
Genital Diseases, Female Oxaliplatin Neoplasms Endometrial Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms Pharmacologic Actions |