Clinical Trial for Ovarian Cancer (OvaRex®)

December 13, 2007 updated by: Unither Pharmaceuticals

A Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Intravenous OvaRex® MAb-B43.13 as Post Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian, Tubal or Peritoneal Origin

This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This a Phase III, double-blind, placebo-controlled, multi-center study of intravenous OvaRex® MAb-B43.13 as post-chemotherapy consolidation for epithelial carcinoma of ovarian, tubal, or peritoneal origin.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Comprehensive Cancer Institute
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Western Regional Community Clinical Oncology Program
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Hematology Oncology Assoc.
    • California
      • Fullerton, California, United States, 92835
        • St. Jude Medical Center
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095-1740
        • UCLA School of Medicine
      • Newport Beach, California, United States, 92663
        • Gynecologic Oncology Associates
      • Orange, California, United States, 92868
        • University of California, Irvine
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center-Midtown
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Cancer Center
      • Torrington, Connecticut, United States, 06790
        • Northwestern Connecticut Oncology Hematology Associates, LLP
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Gynecologic Oncology
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Pensacola, Florida, United States, 32504
        • Pensacola Research Consultants
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Hospitals
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Gynecologic Oncology
      • South Bend, Indiana, United States, 46617
        • Michiana Hematology Oncology PC
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Louisville Oncology
      • Louisville, Kentucky, United States, 40202
        • Brown Cancer Center
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Medical Surgical Clinic
      • New Orleans, Louisiana, United States, 70115
        • Hematology and Oncology Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21237-3998
        • The Harry and Jeanette Weinberg Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Women's Specialty Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center
    • New Jersey
      • Neptune, New Jersey, United States, 07754
        • Jersey Shore Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York City, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center
      • Nyack, New York, United States, 10960
        • Nyack Hospital
      • Syracuse, New York, United States, 13210
        • SUNY-HSC Syracuse, Crouse Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Blumenthal Cancer Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital - Health Systems
      • Columbus, Ohio, United States, 43222
        • GYN Oncology and Pelvic Surgery Associates
      • Toledo, Ohio, United States, 43606
        • ProMedica Health Systems
      • Toledo, Ohio, United States, 43614-5809
        • Medical College of Ohio Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Cancer Specialists-Northrup
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3180
        • Magee-Womens Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Brown University School of Medicine
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • South Carolina Oncology Associates
      • Greenville, South Carolina, United States, 29601
        • Gynecologic Oncology Research and Development
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga GYN Oncology
      • Memphis, Tennessee, United States, 38120
        • West Clinic, PC
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Dallas, Texas, United States, 75235-9032
        • Univ. of Texas SW Medical Center at Dallas
      • Dallas, Texas, United States, 75246-2006
        • Texas Oncology, PA
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Norfolk, Virginia, United States, 23502
        • VA Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Carilion GYN Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists-Vancouver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin, and their disease is classified as FIGO Stage III or IV. Histological diagnosis must have been confirmed by site pathology review of slides as documented by the site investigator. These slides must be made available for sponsor review.
  • Patients must have had an elevated serum CA125 level (per reference lab normal range) measured prior to or at surgery (i.e., not later than the immediate post-surgery period when the patient is in the surgical recovery room). If a pre-surgical CA125 measurement is not available, then the patient must have had: (a) a serum CA125 level ≥100 U/mL, and (b) tumor tissue that has been demonstrated by immunohistochemical methods to express CA125.
  • Patients must have had a documented serum CA125 level ≤65 U/mL prior to the third cycle of front-line chemotherapy.
  • Patients must have had microscopic or small diameter residual disease following primary de-bulking surgical procedure.
  • Patients must have received chemotherapy that included a platinum compound and a taxane following appropriate staging procedures. Front-line treatment can include no more than 8 cycles of chemotherapy.
  • Patients must have had a complete clinical response to their front-line surgery and chemotherapy. A complete clinical response is defined as one in which the patient had a normal physical examination, no conclusive evidence of residual tumor by CT of the abdomen and pelvis, a normal chest x-ray, and a serum CA125 level at least 5 U/mL but less than 35 U/mL as measured in the pretreatment baseline laboratories by the protocol Central Lab.
  • Patients must have undergone no more than one interval de-bulking procedure.
  • Patients must receive their first dose of study medication between 4 and 12 weeks after completing their last dose of front-line chemotherapy.
  • Patients must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.

Exclusion Criteria:

  • Patients who have received more than one prior regimen of chemotherapy. A change in chemotherapy agents is permitted during the patient's primary therapy provided that the change is considered to be part of the initial chemotherapy treatment regimen.
  • Patients with known refractory or recurrent epithelial adenocarcinoma of ovarian, tubal, or peritoneal origin requiring chemotherapy.
  • Patients who have compromised hematopoietic function (hemoglobin <8.0 g/dL; lymphocyte count <300 mm³; neutrophil count <1000 mm³; platelet count <100,000 mm³.
  • Patients with hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
  • Patients with severe renal dysfunction defined as a serum creatinine >1.6 mg/dL.
  • Patients with a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
  • Patients who have contraindications to the use of pressor agents.
  • Patients being chronically treated with immunosuppressive drugs such as cyclosporin, ACTH, or systemic corticosteroids.
  • Patients who have received immunotherapy (interferons, tumor necrosis factor, other cytokines [e.g., interleukins] or biological response modifiers, or BCG vaccines) within 6 weeks of receiving their first dose of study medication. Patients who have received hemopoietic factors are acceptable.
  • Patients who have had a splenectomy.
  • Patients with uncontrolled diseases other than cancer will be excluded. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
  • Patients who have a concurrent illness or chronically taking medication, which would confound the results of the study, preclude the patient from completing the study, or mask an adverse reaction.
  • Patients who have a concurrent malignancy (except non-melanoma of the skin, in situ carcinoma of cervix), unless the patient received curative treatment and has been disease free for greater than or equal to 5 years.
  • Patients receiving other investigational drugs within 30 days of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unither Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2002

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2002

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OVA-Gy-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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