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
NCT ID: NCT00003634
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
400 participants
INTERVENTIONAL
1998-04-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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oregovomab
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least 300/mm3 Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy No prior murine monoclonal antibodies for diagnostic or therapeutic purposes Chemotherapy: No more than 1 prior regimen of chemotherapy (change in chemotherapy agents is permitted during primary therapy provided that the change is considered to be part of initial chemotherapy regimen) At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior abdominal, abdominopelvic, or pelvic radiotherapy Surgery: At least 4 weeks since prior surgery No more than 1 interval debulking procedure
18 Years
FEMALE
No
Sponsors
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AltaRex
INDUSTRY
Principal Investigators
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Jonathan S. Berek, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Locations
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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
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, 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
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
Québec, Quebec, Canada
Countries
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Other Identifiers
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ALTAREX-OVA-Gy-07
Identifier Type: -
Identifier Source: secondary_id
ALTAREX-961452
Identifier Type: -
Identifier Source: secondary_id
ALTAREX-OVA-Gy-06
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1488
Identifier Type: -
Identifier Source: secondary_id
CDR0000066718
Identifier Type: -
Identifier Source: org_study_id