Brief 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
Official Title
A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
oregovomab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
400
Start Date
April 1998
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jonathan S. Berek, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00003634
Organization ID
CDR0000066718
Secondary IDs
ALTAREX-OVA-Gy-07
Study Sponsor
AltaRex
Study Sponsor
Jonathan S. Berek, MD, Study Chair, Jonsson Comprehensive Cancer Center
Verification Date
May 2007