A randomized, double blind, placebo controlled, multicentre trial of Abagovomab maintenance therapy in patients with epithelial ovarian cancer after complete response to first line chemotherapy. - ND
- Conditions
- Epithelial ovarian cancer.MedDRA version: 6.1Level: PTClassification code 10061328
- Registration Number
- EUCTR2006-002801-30-IT
- Lead Sponsor
- MENARINI RICERCHE S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 870
At a maximum of 8 weeks after the last cycle of 1st line standard platinum/taxane chemotherapy, patients must fulfil all the following inclusion criteria to be eligible for entry into the study 61607; Age 18 years; 61607; Properly executed written informed consent; 61607; History of histological and CA125 35 U/ml confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; 61607; History of debulking surgery and standard platinum/taxane based non-investigational chemotherapy; 61607; Complete clinical response defined as 61692; Normal physical examination; 61692; No symptoms suggestive of persistent cancer; 61692; No definite evidence of disease by computed tomography CT of the abdomen and pelvis within the previous 4 weeks; 61692; Negative chest x-ray or chest CT scan within the previous 4 weeks; 61692; Serum CA125 level 35 U/ml. 61607; Adequate hematologic, renal and hepatic function 61692; ANC 1.5 x 109/l; 61692; Platelets 75 x 109/l; 61692; Haemoglobin 6.2 mmol/l 9.9 mg/dl ; 61692; Serum creatinine 1.5 x ULN; 61692; Bilirubin 1.5 x ULN; AST, ALT, AP 2.5 x ULN. 61607; ECOG Performance Status PS 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients are ineligible to participate in the study, if any of the following criteria are present 61607; 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; 61607; known active autoimmune disease requiring chronic treatment with immunosuppressive agents e.g., rheumatoid arthritis, ulcerative colitis, etc. ; 61607; known immune deficiency e.g. HIV, hypogammaglobulinemia, etc. ; 61607; known infection with hepatitis B, or hepatitis C; 61607; history of recent myocardial infarction 6 months or decompensated heart failure NYHA class III ; 61607; previous or concomitant use of any anti-cancer therapy other than the platinum-taxane 1st line chemotherapy; 61607; concomitant use of any other investigational agent; 61607; any prior investigational anti-cancer vaccine or monoclonal antibody; 61607; known allergy to murine proteins; 61607; any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures; 61607; clinically significant active infection; 61607; concomitant use of any immunosuppressive agent e.g., steroids, cyclosporin, etc. ; 61607; major surgery within the previous 2 weeks; 61607; radiotherapy within the previous 4 weeks; 61607; any significant toxicity from prior chemotherapy; 61607; unreliability or inability to follow protocol requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the benefit in terms of recurrence free survival RFS of Abagovomab vs placebo as maintenance therapy after clinical complete response to debulking surgery and standard platinum/taxane 1st line chemotherapy.;Primary end point(s): Recurrence Free Survival i.e. time from the date of randomization to documentation of disease recurrence or death from any cause .;Secondary Objective: 1. to compare the effect of Abagovomab vs placebo in terms of overall survival OS ; 2. to evaluate the safety and tolerability of repeated doses of Abagovomab; 3. to evaluate the time course of immune response induced by repeated doses of Abagovomab, namely induction of Ab3 and HAMA; 4. to evaluate in a subset of approximately 10 of patients additional immunologic parameters i.e. Ab1 and CA125-specific T cell response .
- Secondary Outcome Measures
Name Time Method