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
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-09-13
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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 criteria: 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

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