Clinical Trial for Ovarian Cancer (OvaRex®)

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00050375
• Other study ID #: OVA-Gy-17
• Status: Terminated
• Phase: Phase 3
• First received: December 5, 2002
• Last updated: December 13, 2007
• Start date: December 2002
• Est. completion date: December 2007

Study information

• Verified date: June 2006
• Source: Unither Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00068354

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 354
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• oregovomab

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Unither Pharmaceuticals

Country where clinical trial is conducted

United States,