A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

Inclusion Criteria:

   - have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin
   and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage
   III/IV disease.

   - have preoperative CA125 levels > 50 U/mL

   - have optimal cytoreduction (RT<1)

   - be anticipated to have first-line chemotherapy infusion within 6 weeks after surgery

   - be available to complete the protocol for the duration of the study

   - have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or
   equal to 1,500/µL, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1.
   Platelets greater than or equal to 100,000/µL; hemoglobin greater than or equal to 8.0
   g/dL

   - have adequate Renal function: creatinine less than or equal to 1.5 x institutional
   upper limit normal (ULN), CTCAE v3.0 grade 1

   - have adequate Hepatic function: bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0
   grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0
   grade 1)

   - able to sign informed consent and provide authorization permitting release of personal
   health information

   - have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

   - have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus
   erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS),
   ankylosing spondylitis)

   - have a known allergy to murine proteins or have had a documented anaphylactic reaction
   to any drug, or cannot tolerate cyclophosphamide

   - are being chronically treated with immunosuppressive drugs such as cyclosporin,
   adrenocorticotropic hormone (ACTH), or systemic corticosteroids.

   - have a recognized immunodeficiency disease including cellular immunodeficiencies,
   hypogammaglobulinemia or dysgammaglobulinemia

   - have an acquired, hereditary, or congenital immunodeficiency

   - have uncontrolled diseases other than cancer

   - have contraindications to the use of pressor agents

   - have undergone more than one surgical debulking

   - have hepatic dysfunction, eg, bilirubin more than 1.5 times higher than normal levels,
   lactate dehydrogenase (LDH), serum glutamic oxaloacetic transaminase (SGOT) and serum
   glutamic pyruvic transaminase (SGPT) doubled compared to normal or albumin <3.5 g/dL

   - have severe renal insufficiency with serum creatinine >1.6 mg/dL

   - have concomitant diseases or treatments that may confound the results of the study,
   which may preclude the completion of the protocol or may mask adverse reactions

   - are to be tested with other medications during treatment

   - are unable to read or understand or unable to sign the necessary written consent
   before starting treatment