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NCT00003634 Clinical Trial

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

Ovarian Cancer Clinical Trial

Official title:
A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00003634
Other study ID # CDR0000066718
Secondary ID ALTAREX-OVA-Gy-0
Status Active, not recruiting
Phase Phase 2
First received November 1, 1999
Last updated November 5, 2013
Start date April 1998

Study information
Verified date May 2007
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• oregovomab

Locations
Country Name City State
Canada Tom Baker Cancer Center - Calgary Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Centre Universitaire de Sante de l'Estrie Fleurimont Quebec
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 Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada Jewish General Hospital - Montreal Montreal Quebec
Canada Ottawa Regional Cancer Center - General Division Ottawa Ontario
Canada Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec Quebec City Quebec
Canada Saint John Regional Hospital Saint John New Brunswick
Canada Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario
Canada British Columbia Cancer Agency - Fraser Valley Cancer Centre Surrey British Columbia
Canada Toronto Sunnybrook Regional Cancer Centre Toronto Ontario
Canada British Columbia Cancer Agency Vancouver British Columbia
Canada Manitoba Cancer Treatment and Research Foundation Winnipeg Manitoba
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Alta Bates Comprehensive Cancer Center Berkeley California
United States New England Medical Center Hospital Boston Massachusetts
United States Cancer Center, University of Virginia HSC Charlottesville Virginia
United States University of Chicago Cancer Research Center Chicago Illinois
United States Ellis Fischel Cancer Center Columbia Missouri
United States University of Texas Southwestern Medical School Dallas Texas
United States University of Colorado Cancer Center Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States Saint Mary's Hospital East Saint Louis Illinois
United States Patty Berg Cancer Center Fort Myers Florida
United States U.S. Oncology Houston Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Florida Health Science Center - Jacksonville Jacksonville Florida
United States Baptist Regional Cancer Center - Knoxville Knoxville Tennessee
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States North Shore University Hospital Manhasset New York
United States University of Minnesota Medical School Minneapolis Minnesota
United States Alton Ochsner Medical Foundation Hospital New Orleans Louisiana
United States University of Oklahoma Oklahoma City Oklahoma
United States Chao Family Comprehensive Cancer Center Orange California
United States Walt Disney Memorial Cancer Institute Orlando Florida
United States Lutheran General Cancer Care Center Park Ridge Illinois
United States Wilshire Oncology Medical Center Pomona California
United States Swedish Hospital Tumor Institute Seattle Washington
United States Spartanburg Regional Medical Center Spartanburg South Carolina
United States Stanford University School of Medicine Stanford California
United States State University of New York - Upstate Medical University Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
AltaRex

Countries where clinical trial is conducted

United States,  Canada, 

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