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A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease


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

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease


OBJECTIVES: I. Determine the safety of OvaRex monoclonal antibody B43.13 in patients with
elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary, fallopian
tube, or peritoneum, but without other evidence of disease. II. Determine the time to
disease progression, overall survival, CA 125 levels, immune responses, and quality of life
of these patients treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms: Arm I: Patients receive placebo IV during weeks 1, 3, 5, 9, 13, 25, 37, and
49. Arm II: Patients receive OvaRex monoclonal antibody B43.13 (MOAB B43.13) IV during weeks
1, 3, 5, 9, 13, 25, 37, and 49. Patients in either treatment arm who have no disease
progression after week 49 receive MOAB B43.13 once every 12 weeks until week 121. Patients
with disease progression after week 49 may receive MOAB B43.13 alone, in combination with,
or following chemotherapy. Quality of life is assessed during the study.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven epithelial adenocarcinoma of the ovary,
fallopian tube, or peritoneum CA 125 greater than 35 U/mL No conclusive radiological or
clinical evidence of disease No disease recurrence Must have received only 1 prior
platinum based chemotherapy regimen No tumors of low malignant potential or noninvasive
disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least
1,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 2 mg/dL
Cardiovascular: No uncontrolled hypertension No congestive heart failure No arrhythmias
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No active autoimmune disease requiring chronic treatment No allergy to
murine proteins No documented anaphylactic reaction to any drug No active infection
causing fever No immunodeficiency disease No uncontrolled nonmalignant diseases No other
malignancy (except nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless
curatively treated and free of disease for at least 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibodies
Chemotherapy: See Disease Characteristics At least 4 weeks since prior platinum based
chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At
least 6 months since prior limited field (i.e., abdominal or pelvic) radiotherapy No prior
whole abdominal radiotherapy Surgery: At least 4 weeks since prior surgery No prior
splenectomy Other: At least 4 weeks since prior immunosuppressive drugs No concurrent
immunosuppressive drugs At least 30 days since other prior investigational drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael A. Bookman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067265

NCT ID:

NCT00004064

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial 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

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Texas Oncology, P.A.Dallas, Texas  75246
Palmetto Richland Memorial HospitalColumbia, South Carolina  29203
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Mercy Medical Center, Inc.Baltimore, Maryland  21202
Gynecologic Oncology AssociatesNewport Beach, California  92663
Lee Memorial Health SystemFort Myers, Florida  33902
Riverside Regional Medical CenterNewport News, Virginia  23601