Clinical Trial for Ovarian Cancer (OvaRex®)

NCT00050375 | Terminated Phase 3

• 1 other identifier: OVA-Gy-17
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 62

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.

Conditions

Ovarian Cancer

Keywords

OvaRex; ovarian; CA125; murine; antibody; immunotherapy

Interventions

oregovomab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unither Pharmaceuticals: lead

Study Sites (62)

Comprehensive Cancer Institute

Huntsville, Alabama, 35801, United States

Location

Western Regional Community Clinical Oncology Program

Phoenix, Arizona, 85006, United States

Location

Little Rock Hematology Oncology Assoc.

Little Rock, Arkansas, 72205, United States

Location

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Wilshire Oncology Medical Group

La Verne, California, 91750, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UCLA School of Medicine

Los Angeles, California, 90095-1740, United States

Location

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Rocky Mountain Cancer Center-Midtown

Denver, Colorado, 80218, United States

Location

University of Connecticut Cancer Center

Farmington, Connecticut, 06030, United States

Location

Northwestern Connecticut Oncology Hematology Associates, LLP

Torrington, Connecticut, 06790, United States

Location

Florida Gynecologic Oncology

Fort Myers, Florida, 33901, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Pensacola Research Consultants

Pensacola, Florida, 32504, United States

Location

H. Lee Moffitt Cancer Center and Research

Tampa, Florida, 33612-9497, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

The University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

St. Vincent Gynecologic Oncology

Indianapolis, Indiana, 46260, United States

Location

Michiana Hematology Oncology PC

South Bend, Indiana, 46617, United States

Location

Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Louisville Oncology

Louisville, Kentucky, 40202, United States

Location

Lake Charles Medical Surgical Clinic

Lake Charles, Louisiana, 70601, United States

Location

Hematology and Oncology Specialists

New Orleans, Louisiana, 70115, United States

Location

The Harry and Jeanette Weinberg Cancer Institute

Baltimore, Maryland, 21237-3998, United States

Location

New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Women's Specialty Center

Jackson, Mississippi, 39202, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07754, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

St. Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Nyack Hospital

Nyack, New York, 10960, United States

Location

SUNY-HSC Syracuse, Crouse Hospital

Syracuse, New York, 13210, United States

Location

Blumenthal Cancer Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospital - Health Systems

Cleveland, Ohio, 44106, United States

Location

GYN Oncology and Pelvic Surgery Associates

Columbus, Ohio, 43222, United States

Location

ProMedica Health Systems

Toledo, Ohio, 43606, United States

Location

Medical College of Ohio Cancer Institute

Toledo, Ohio, 43614-5809, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Northwest Cancer Specialists-Northrup

Portland, Oregon, 97210, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Brown University School of Medicine

Providence, Rhode Island, 02905, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29203, United States

Location

Gynecologic Oncology Research and Development

Greenville, South Carolina, 29601, United States

Location

Chattanooga GYN Oncology

Chattanooga, Tennessee, 37403, United States

Location

West Clinic, PC

Memphis, Tennessee, 38120, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Univ. of Texas SW Medical Center at Dallas

Dallas, Texas, 75235-9032, United States

Location

Texas Oncology, PA

Dallas, Texas, 75246-2006, United States

Location

Texas Oncology

Fort Worth, Texas, 76104, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

VA Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Carilion GYN Oncology Associates

Roanoke, Virginia, 24014, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

Northwest Cancer Specialists-Vancouver

Vancouver, Washington, 98684, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

oregovomab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 5, 2002
• First Posted: December 6, 2002
• Study Start: December 1, 2002
• Study Completion: December 1, 2007
• Last Updated: December 18, 2007

Record last verified: 2006-06

Locations

US (62)