A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

Inclusion Criteria:

At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane
intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the
following inclusion criteria:

- Age >/= 18 years;

- Properly executed written informed consent;

- History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV
epithelial ovarian, fallopian tube, or primary peritoneal cancer;

- History of debulking surgery and 6-8 cycles of standard platinum/taxane based
non-investigational IV-IP chemotherapy;

- Complete clinical response defined as:

- Normal physical examination;

- No symptoms suggestive of persistent cancer;

- No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis
within the previous 4 weeks;

- Negative chest x-ray (or chest CT scan) within the previous 4 weeks;

- Serum CA125 within the normal laboratory range.

- Adequate hematologic, renal and hepatic function:

- Absolute Neutrophil Count (ANC) >/=1.5 * 109/l;

- Platelets >/= 75 * 109/l;

- Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl);

- Serum creatinine
- Bilirubin
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Exclusion Criteria:

Patients are ineligible to participate in the study, if any of the following criteria are
present:

- any other invasive malignancies, with the exception of non-melanoma skin cancer or
cervical carcinoma in situ, within the last 5 years or whose previous cancer
treatment contraindicates this protocol therapy;

- known active autoimmune disease requiring chronic treatment with immunosuppressive
agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);

- known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);

- known infection with hepatitis B, or hepatitis C;

- history of recent myocardial infarction ( (New York Heart Association - NYHA class >/= III);

- previous or concomitant use of any anti-cancer therapy other than the platinum-taxane
based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation
therapy is not permitted after completion of standard front line chemotherapy.

- concomitant use of any other investigational agent;

- any prior investigational anti-cancer vaccine or monoclonal antibody;

- known allergy to murine proteins;

- any significant medical or psychiatric condition, drug or alcohol abuse that might
prevent the patient from complying with all study procedures;

- clinically significant active infection;

- concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.);

- major surgery within the previous 2 weeks;

- radiotherapy within the previous 4 weeks;

- any significant toxicity from prior chemotherapy;

- unreliability or inability to follow protocol requirements;

- potentially childbearing and not willing to use adequate contraceptive methods
throughout the entire study period;

- pregnancy.