- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003634
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
A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Surrey, British Columbia, Canada, V3V 1Z2
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- Manitoba Cancer Treatment and Research Foundation
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Regional Cancer Center - General Division
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- Centre Universitaire de Sante de l'Estrie
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Montreal, Quebec, Canada, H2W-W1T8
- Centre Hospitalier de l'Université de Montréal
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital - Montreal
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
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California
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Berkeley, California, United States, 94704
- Alta Bates Comprehensive Cancer Center
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Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Pomona, California, United States, 91767
- Wilshire Oncology Medical Center
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Stanford, California, United States, 94305-5317
- Stanford University School of Medicine
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
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Florida
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Fort Myers, Florida, United States, 33901
- Patty Berg Cancer Center
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Jacksonville, Florida, United States, 32209
- University of Florida Health Science Center - Jacksonville
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Orlando, Florida, United States, 32804
- Walt Disney Memorial Cancer Institute
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Cancer Research Center
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East Saint Louis, Illinois, United States, 62201
- Saint Mary's Hospital
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Park Ridge, Illinois, United States, 60068
- Lutheran General Cancer Care Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Alton Ochsner Medical Foundation Hospital
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02111
- New England Medical Center Hospital
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical School
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center
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New York
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma
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South Carolina
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Regional Medical Center
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Tennessee
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Knoxville, Tennessee, United States, 37901
- Baptist Regional Cancer Center - Knoxville
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Texas
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Dallas, Texas, United States, 75235-9032
- University of Texas Southwestern Medical School
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Houston, Texas, United States, 77060
- U.S. Oncology
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Virginia
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Charlottesville, Virginia, United States, 22908
- Cancer Center, University of Virginia HSC
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Washington
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Seattle, Washington, United States, 98104
- Swedish Hospital Tumor Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma Must have had complete clinical response to primary therapy consisting of surgical debulking and platinum based chemotherapy Elevated CA 125 (greater than 35 U/mL) prior to or at surgery (if presurgical CA 125 measurement is not available, patient must have a serum CA 125 of at least 100 U/mL and strong tumor tissue expression) Must have residual disease (visible or palpable) at completion of the staging laparotomy (IIIB and IIIC microscopic disease)
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jonathan S. Berek, MD, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066718
- ALTAREX-OVA-Gy-07
- ALTAREX-961452
- ALTAREX-OVA-Gy-06
- NCI-V98-1488
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
Clinical Trials on oregovomab
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Unither PharmaceuticalsTerminated
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Unither PharmaceuticalsTerminatedOvarian NeoplasmsCanada, United States
-
Unither PharmaceuticalsTerminatedOvarian NeoplasmsUnited States
-
AltaRexUnknownOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited States, Canada
-
Unither PharmaceuticalsTerminated
-
Quest PharmaTech Inc.CompletedOvarian NeoplasmsUnited States
-
National Cancer Centre, SingaporeBristol-Myers Squibb; OncoQuest Pharma USA Inc.UnknownEpithelial Ovarian CancerSingapore
-
National Cancer Centre, SingaporeTerminatedEpithelial Ovarian CancerSingapore
-
CanariaBio Inc.TerminatedOvary Cancer | Ovarian Cancer Stage IV | Neoplasms, Ovarian | Ovarian Cancer Stage III | Ovarian Cancer Recurrent | Cancer of OvaryUnited States
-
CanariaBio Inc.Veristat, LLCActive, not recruitingPeritoneal Cancer | Recurrent Ovarian Cancer | Recurrent Fallopian Tube Cancer | Recurrent Epithelial Cancer of Ovary | Recurrent Epithelial Ovarian Cancer | Recurrent Carcinoma of Ovary | Adenocarcinoma of OvaryUnited States