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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004115 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is more effective than observation for ovarian cancer or primary peritoneal cancer that is in remission.
PURPOSE: Randomized phase III trial to compare the effectiveness of monoclonal antibody therapy with that of observation in treating patients who have ovarian cancer or primary peritoneal cancer in remission following surgery and chemotherapy.
Condition | Intervention | Phase |
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Ovarian Cancer Peritoneal Cavity Cancer |
Radiation: yttrium Y 90 monoclonal antibody HMFG1 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Multicenter Randomized Survival Study of Monoclonal Antibody Radioimmunotherapy: A Multinational Study in Patients With Ovarian Carcinoma Using the HMFG1 Antibody Labeled With 90Yttrium |
Study Start Date: | December 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, parallel, multicenter study. Patients are randomized to one of two treatment arms.
Patients in arm I are followed at weeks 1, 4, and 8. Patients in arm II are followed weekly for 6 weeks and at weeks 8 and 12. All patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 420 patients (210 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prior complete response to 1 platinum-based chemotherapy regimen consisting of at least 5 courses
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Antisoma | |
London, England, United Kingdom, W5 3QR |
Study Chair: | Jonathan S. Berek, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067341, UCLA-9712040, ANTISOMA-SMART22, NCI-G99-1604 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004115 History of Changes |
Health Authority: | United States: Federal Government |
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer |
Ovarian Neoplasms Digestive System Neoplasms Immunologic Factors Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Carcinoma |
Antibodies, Monoclonal Genital Diseases, Female Antibodies Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Immunoglobulins Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Immunologic Factors Gonadal Disorders Physiological Effects of Drugs Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions |
Adnexal Diseases Antibodies, Monoclonal Genital Diseases, Female Antibodies Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Immunoglobulins Endocrine Gland Neoplasms |