Clinical trial NCT00050375: Clinical Trial for Ovarian Cancer (OvaRex®)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: OvaRex
ovarian
CA125
murine
antibody
immunotherapy
Lead sponsor: Unither Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-12-06
Enrollment: 354
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
city: Phoenix
country: United States
facility: Western Regional Community Clinical Oncology Program
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Hematology Oncology Assoc.
state: Arkansas
city: Fullerton
country: United States
facility: St. Jude Medical Center
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center-Midtown
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Cancer Center
state: Connecticut
city: Torrington
country: United States
facility: Northwestern Connecticut Oncology Hematology Associates, LLP
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Gynecologic Oncology
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Hospitals
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Gynecologic Oncology
state: Indiana
city: South Bend
country: United States
facility: Michiana Hematology Oncology PC
state: Indiana
city: Louisville
country: United States
facility: Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Louisville Oncology
state: Kentucky
city: Lake Charles
country: United States
facility: Lake Charles Medical Surgical Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Hematology and Oncology Specialists
state: Louisiana
city: Baltimore
country: United States
facility: The Harry and Jeanette Weinberg Cancer Institute
state: Maryland
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: Women's Specialty Center
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: Neptune
country: United States
facility: Jersey Shore Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York City
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: Nyack
country: United States
facility: Nyack Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY-HSC Syracuse, Crouse Hospital
state: New York
city: Charlotte
country: United States
facility: Blumenthal Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospital - Health Systems
state: Ohio
city: Columbus
country: United States
facility: GYN Oncology and Pelvic Surgery Associates
state: Ohio
city: Toledo
country: United States
facility: ProMedica Health Systems
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio Cancer Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Northwest Cancer Specialists-Northrup
state: Oregon
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Brown University School of Medicine
state: Rhode Island
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Greenville
country: United States
facility: Gynecologic Oncology Research and Development
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga GYN Oncology
state: Tennessee
city: Memphis
country: United States
facility: West Clinic, PC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Dallas
country: United States
facility: Univ. of Texas SW Medical Center at Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Norfolk
country: United States
facility: VA Oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Carilion GYN Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists-Vancouver
state: Washington
Study officials:
References: