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

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

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