EUCTR2006-002801-30-BE进行中（未招募）不适用
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
MENARINI RICERCHE S.p.A0 个研究点目标入组 870 人开始时间: 2006年10月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 870
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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 g/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
排除标准
- •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 based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front-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)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.
研究者
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