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	Treatment or Intervention	Phase
Ovarian Cancer	Drug: oregovomab	Phase III

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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.

Arizona
      Greater Phoenix Community Clinical Oncology Program, Phoenix,  Arizona,  85006,  United States; Recruiting
Arkansas
      Little Rock Hematology Oncology Assoc., Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Wilshire Oncology Medical Group, La Verne,  California,  91750,  United States; Recruiting
      St. Jude Medical Center, Fullerton,  California,  92835,  United States; Recruiting
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
      Gynecologic Oncology Associates, Newport Beach,  California,  92663,  United States; Recruiting
      UCLA School of Medicine, Los Angeles,  California,  90095-1740,  United States; Recruiting
      Stanford University, Stanford,  California,  94305,  United States; Recruiting
      University of California, Irvine, Orange,  California,  92868,  United States; Recruiting
Colorado
      Rocky Mountain Cancer Center-Midtown, Denver,  Colorado,  80218,  United States; Recruiting
Connecticut
      Northwestern Connecticut Oncology Hematology Associates, LLP, Torrington,  Connecticut,  06790,  United States; Recruiting
      University of Connecticut Cancer Center, Farmington,  Connecticut,  06030,  United States; Recruiting
Florida
      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States; Recruiting
      Florida Gynecologic Oncology, Fort Myers,  Florida,  33901,  United States; Recruiting
      H. Lee Moffitt Cancer Center and Research, Tampa,  Florida,  33612-9497,  United States; Recruiting
      Pensacola Research Consultants, Pensacola,  Florida,  32504,  United States; Recruiting
Georgia
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States; Recruiting
Illinois
      The University of Chicago Hospitals, Chicago,  Illinois,  60637,  United States; Recruiting
Indiana
      Michiana Hematology Oncology PC, South Bend,  Indiana,  46617,  United States; Recruiting
      St. Vincent Gynecologic Oncology, Indianapolis,  Indiana,  46260,  United States; Recruiting
Kentucky
      Louisville Oncology, Louisville,  Kentucky,  40202,  United States; Recruiting
      Brown Cancer Center, Louisville,  Kentucky,  40202,  United States; Recruiting
Louisiana
      Lake Charles Medical Surgical Clinic, Lake Charles,  Louisiana,  70601,  United States; Recruiting
      Hematology and Oncology Specialists, New Orleans,  Louisiana,  70115,  United States; Recruiting
Maryland
      Franklin Square Hospital, Baltimore,  Maryland,  21237-3998,  United States; Recruiting
Massachusetts
      New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Mississippi
      Women's Specialty Center, Jackson,  Mississippi,  39202,  United States; Recruiting
Missouri
      Ellis Fischel Cancer Center, Columbia,  Missouri,  65203,  United States; Recruiting
      University of Washington School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
New Jersey
      Jersey Shore Medical Center, Neptune,  New Jersey,  07754,  United States; Recruiting
New Mexico
      San Juan Oncology Associates, Farmington,  New Mexico,  87401,  United States; Recruiting
New York
      St. Vincent's Comprehensive Cancer Center, New York City,  New York,  10011,  United States; Recruiting
      SUNY-HSC Syracuse, Crouse Hospital, Syracuse,  New York,  13210,  United States; Recruiting
      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
      Nyack Hospital, Nyack,  New York,  10960,  United States; Recruiting
North Carolina
      Blumenthal Cancer Center, Charlotte,  North Carolina,  28203,  United States; Recruiting
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      GYN Oncology and Pelvic Surgery Associates, Columbus,  Ohio,  43222,  United States; Recruiting
      Medical College of Ohio Cancer Institute, Toledo,  Ohio,  43614-5809,  United States; Recruiting
      University Hospital - Health Systems, Cleveland,  Ohio,  44106,  United States; Recruiting
      ProMedica Health Systems, Toledo,  Ohio,  43606,  United States; Recruiting
Oklahoma
      Oklahoma University Health Sciences Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      Northwest Cancer Specialists-Northrup, Portland,  Oregon,  97210,  United States; Recruiting
Pennsylvania
      Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Rhode Island
      Brown University School of Medicine, Providence,  Rhode Island,  02905,  United States; Recruiting
South Carolina
      South Carolina Oncology Associates, Columbia,  South Carolina,  29203,  United States; Recruiting
      Gynecologic Oncology Research and Development, Greenville,  South Carolina,  29601,  United States; Recruiting
Tennessee
      Chattanooga GYN Oncology, Chattanooga,  Tennessee,  37403,  United States; Recruiting
      West Clinic, PC, Memphis,  Tennessee,  38120,  United States; Recruiting
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      Arlington Cancer Center, Arlington,  Texas,  76012,  United States; Recruiting
      Southwest Regional Cancer Center, Austin,  Texas,  78705,  United States; Recruiting
      Univ. of Texas SW Medical Center at Dallas, Dallas,  Texas,  75235-9032,  United States; Recruiting
      Texas Oncology, PA, Dallas,  Texas,  75246-2006,  United States; Recruiting
      Texas Oncology, Fort Worth,  Texas,  76104,  United States; Recruiting
      Texas Cancer Care, Fort Worth,  Texas,  76104,  United States; Recruiting
Utah
      Utah Cancer Specialists, Salt Lake City,  Utah,  84106,  United States; Recruiting
Virginia
      VA Oncology Associates, Newport News,  Virginia,  23606,  United States; Recruiting
      University of Virginia Cancer Center, Charlottesville,  Virginia,  22908,  United States; Recruiting
Washington
      Swedish Medical Center, Seattle,  Washington,  98104,  United States; Recruiting
      Northwest Cancer Specialists-Vancouver, Vancouver,  Washington,  98684,  United States; Recruiting
Wisconsin
      Oncology of Wisconsin, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study ID Numbers:  OVA-Gy-17
Record last reviewed:  October 2004
Record first received:  December 5, 2002
ClinicalTrials.gov Identifier:  NCT00050375
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10