EUCTR2006-002801-30-HU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11月20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 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
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 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.
研究者
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