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-HU
• Lead Sponsor: MENARINI RICERCHE S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-20
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 870

Inclusion Criteria

At a maximum of 12 weeks after the last cycle of 1st line IV or IP 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

Exclusion Criteria

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 treatment has been clarified with regard to the exception of the allowed chemotherapy for ovarian cancer, so that it is fully aligned with the forth inclusion criterion detailing the first line chemotherapy for the ovarian cancer;
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)Concomitant 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;
17)Potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period;
18)Pregnancy.

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).