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 Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Pharmaceutical / Industry	ALTAREX-OVA-Gy-07 ALTAREX-961452, ALTAREX-OVA-Gy-06, NCI-V98-1488, NCT00003634

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.

Entry 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)

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

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

Expected Enrollment

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

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.  

Trial Contact Information

Trial Lead Organizations

AltaRex Corporation

Jonathan Berek, MD, Protocol chair(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719

Registry Information
Official Title		A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
Trial Start Date		1998-04-01
Registered in ClinicalTrials.gov		NCT00003634
Date Submitted to PDQ		1998-10-12
Information Last Verified		2007-05-31