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

Phase 2
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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

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

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jonathan S. Berek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
State University of New York - Upstate Medical University Syracuse, New York  13210
New England Medical Center Hospital Boston, Massachusetts  02111
Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
Henry Ford Hospital Detroit, Michigan  48202
University of Minnesota Medical School Minneapolis, Minnesota  55455
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
North Shore University Hospital Manhasset, New York  11030
Swedish Hospital Tumor Institute Seattle, Washington  98104
University of Texas Southwestern Medical School Dallas, Texas  75235-9032
Walt Disney Memorial Cancer Institute Orlando, Florida  32803
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
University of Florida Health Science Center - Jacksonville Jacksonville, Florida  32209
Wilshire Oncology Medical Center Pomona, California  91767
Stanford University School of Medicine Stanford, California  94305-5317
Patty Berg Cancer Center Fort Myers, Florida  33901
Saint Mary's Hospital East Saint Louis, Illinois  62201
Alton Ochsner Medical Foundation Hospital New Orleans, Louisiana  70121
Ellis Fischel Cancer Center Columbia, Missouri  65203
University of Oklahoma Oklahoma City, Oklahoma  73190
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
U.S. Oncology Houston, Texas  77060