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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006089 |
Purpose
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Biological: trastuzumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy |
| Estimated Enrollment: | 42 |
| Study Start Date: | March 2001 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days 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: A total of 25-42 patients will be accrued for this study within 12 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial adenocarcinoma
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal therapy
Radiotherapy:
Surgery:
Other
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Banner Baywood Medical Center | |
| Mesa, Arizona, United States, 85206 | |
| Banner Desert Medical Center | |
| Mesa, Arizona, United States, 85202 | |
| Banner Good Samaritan Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Thunderbird Medical Center | |
| Glendale, Arizona, United States, 85306 | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Todd Cancer Institute at Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90801 | |
| United States, Colorado | |
| McKee Medical Center | |
| Loveland, Colorado, United States, 80539 | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631 | |
| Rocky Mountain Gynecologic Oncology | |
| Englewood, Colorado, United States, 80110 | |
| United States, District of Columbia | |
| Washington Cancer Institute at Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | |
| Jupiter, Florida, United States, 33458 | |
| United States, Illinois | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Evanston Northwestern Healthcare - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Anthony's Memorial Hospital | |
| Effingham, Illinois, United States, 62401 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| Howard Community Hospital at Howard Regional Health System | |
| Kokomo, Indiana, United States, 46904 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Louisville Oncology at Norton Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Tufts-NEMC Cancer Center | |
| Boston, Massachusetts, United States, 02111 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| St Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, Ohio | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710-1799 | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Cleveland Clinic Cancer Center at Fairview Hospital | |
| Cleveland, Ohio, United States, 44111 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Lake/University Ireland Cancer Center | |
| Mentor, Ohio, United States, 44060 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234 | |
| United States, Virginia | |
| Carilion Gynecologic Oncology Associates | |
| Roanoke, Virginia, United States, 24014 | |
| University of Virginia Cancer Center at UV Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Wisconsin | |
| Marshfield Clinic - Indianhead Center | |
| Rice Lake, Wisconsin, United States, 54868 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Study Chair: | Gini F. Fleming, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000068091, GOG-0181-B |
| Study First Received: | August 3, 2000 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006089 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
stage III endometrial carcinoma stage IV endometrial carcinoma recurrent endometrial carcinoma endometrial adenocarcinoma |
|
Genital Diseases, Female Neoplasms Endometrial Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Trastuzumab Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms Pharmacologic Actions |