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Clinical Trial for Ovarian Cancer (OvaRex®)
This study has been terminated.
( Study closed by sponser )
First Received: December 5, 2002   Last Updated: December 13, 2007   History of Changes
Sponsor: Unither Pharmaceuticals
Information provided by: Unither Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00050375
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: oregovomab
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Unither Pharmaceuticals:

Estimated Enrollment: 354
Study Start Date: December 2002
Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050375

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

No publications provided

Study ID Numbers: OVA-Gy-17
Study First Received: December 5, 2002
Last Updated: December 13, 2007
ClinicalTrials.gov Identifier: NCT00050375     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Unither Pharmaceuticals:
OvaRex
ovarian
CA125
murine
antibody
immunotherapy

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009