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Clinical Trial for Ovarian Cancer (OvaRex®) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Clinical Trial for Ovarian Cancer (OvaRex®)

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

NCT00050375•Unither Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+4 more criteria

Locations (62)

Comprehensive Cancer Institute

Huntsville, Alabama, United States

Western Regional Community Clinical Oncology Program

Phoenix, Arizona, United States

Little Rock Hematology Oncology Assoc.

Little Rock, Arkansas, United States

St. Jude Medical Center

Fullerton, California, United States

Wilshire Oncology Medical Group

La Verne, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

UCLA School of Medicine

Los Angeles, California, United States

Gynecologic Oncology Associates

Newport Beach, California, United States

University of California, Irvine

Orange, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Key Dates

Start Date

December 1, 2002

Completion Date

December 1, 2007

Last Updated

December 18, 2007

Enrollment

354

Estimated participants

Conditions

Ovarian Cancer

Interventions

oregovomab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Trial for Ovarian Cancer (OvaRex®)

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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