Spots Global Cancer Trial Database for Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy
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Trial Identification
Brief Title: Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy
Official Title: A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
Study ID: NCT00003634
Interventions
Study Description
Brief Summary: 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 giving monoclonal antibody therapy is more effective than a placebo in treating patients with ovarian epithelial, fallopian tube, or peritoneal cancer who have responded to surgery and chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients with residual disease from stage III or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer following surgery and chemotherapy.
Detailed Description: OBJECTIVES: I. Compare the time to disease relapse, survival, and quality of life of patients with stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma treated with OvaRex monoclonal antibody B43.13 OR placebo following complete clinical response to primary therapy. II. Determine the safety of this regimen in these patients. III. Assess the immune response of patients treated with this regimen. OUTLINE: This is a randomized study. Patients undergo a laparotomy and platinum based chemotherapy prior to randomization. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive OvaRex monoclonal antibody B43.13 IV on day 0. Treatment continues at 4, 8, 20, 32, 44, and 56 weeks, and then every 3 months in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive placebo IV on day 0. Placebo administration continues on the same schedule as in arm I. Patients presenting with relapse are provided with second line chemotherapy. Quality of life is assessed at the beginning of the study, after 2 months, and then every 3 months thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
Wilshire Oncology Medical Center, Pomona, California, United States
Stanford University School of Medicine, Stanford, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Patty Berg Cancer Center, Fort Myers, Florida, United States
University of Florida Health Science Center - Jacksonville, Jacksonville, Florida, United States
Walt Disney Memorial Cancer Institute, Orlando, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Saint Mary's Hospital, East Saint Louis, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Alton Ochsner Medical Foundation Hospital, New Orleans, Louisiana, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
University of Minnesota Medical School, Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center, Columbia, Missouri, United States
North Shore University Hospital, Manhasset, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Baptist Regional Cancer Center - Knoxville, Knoxville, Tennessee, United States
University of Texas Southwestern Medical School, Dallas, Texas, United States
U.S. Oncology, Houston, Texas, United States
Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States
Swedish Hospital Tumor Institute, Seattle, Washington, United States
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Manitoba Cancer Treatment and Research Foundation, Winnipeg, Manitoba, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Credit Valley Hospital, Mississauga, Ontario, Canada
Ottawa Regional Cancer Center - General Division, Ottawa, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Centre Universitaire de Sante de l'Estrie, Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Jewish General Hospital - Montreal, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec, Quebec City, Quebec, Canada
Contact Details
Name: Jonathan S. Berek, MD
Affiliation: Jonsson Comprehensive Cancer Center
Role: STUDY_CHAIR
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