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
- Conditions
- Epithelial Ovarian Cancer
- Registration Number
- EUCTR2006-002801-30-CZ
- Lead Sponsor
- MENARINI RICERCHE S.p.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 888
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 in to study;
1)Age = 18 years;
2)Properly executed written informed consent;
3)History of histological and CA125 (>35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian,fallopian tube,or primary peritoneal cancer;
4)History of debulking surgery and standard platinum/taxane based non-investigational chemotherapy;
5)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 CA 125 level = 35 U/ml.
6)Adequate haematologic, renal and hepatic function:
- ANC = 1.5 x 10(9)/l;
- Platelets = 75 x 10(9)/l;
- Haemoglobin = 6.2 mmol/l (= 9.9 mg/dl);
- Serum creatinine = 1.5 x ULN;
- Bilirubin = 1.5 x ULN; AST, ALT, AP = 2.5 x ULN.
7)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:
1)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;
2)Known active autoimmune disease requiring chronic treatment with immunosuppressive agents(e.g. rheumatoid arthritis, ulcerative colitis,etc.);
3)Known immune deficiency (e.g. HIV,hypogammaglobulinemia,etc.);
4)Known infection with hepatitis B, or hepatitis C;
5)History of recent myocardial infarction (= 6 months) or decompensated heart failure(NYHA class = III);
6)Previous or concomitant use of any anti-cancer therapy other than the platinum-taxane 1st line chemotherapy;
7)Concomitant use of any other Investigational agent;
8)Any prior investigational anti-cancer vaccine or monoclonal antibody;
9)Known allergy to murine proteins;
10)Any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures;
11)Clinically significant active infection;
12)Concomiant use of any immunosuppresive agent (e.g., steroids, cyclosporin, etc.);
13)Major surgery within the previous 2 weeks;
14)Radiotherapy within the previous 4 weeks;
15)Any significant toxicity from prior chemotherapy;
16)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.;Secondary Objective: 1)To compare the effect of Abagovomab vs placebo in terms of overall survival(OS)<br>2)To evaluate the safety and tolerability of repeated doses of Abagovomab<br>3)To evaluate the time course of immune response induced by repeated doses of Abagovomab, namely induction of Ab3 and HAMA<br>4)To evaluate in a subset of approximately 10% of patients additional immunologic parameters (i.e. Ab1 and CA125-specific T cell response);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 Outcome Measures
Name Time Method