Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Pharmaceutical / Industry	ALTAREX-OVA-Gy-10 OU-08111, NCT00004064

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.

Entry 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 

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

AltaRex Corporation

Michael Bookman, MD, Protocol chair		Ph: 215-728-2987; 888-369-2427 Email: ma_bookman@fccc.edu

Registry Information
Official Title		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
Trial Start Date		1998-11-18
Registered in ClinicalTrials.gov		NCT00004064
Date Submitted to PDQ		1999-08-10
Information Last Verified		2007-06-01