EUCTR2006-002801-30-DE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12月18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 first 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 of 6-8 cycles of standard platinum/taxane based non-investigational IV/IP 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 within normal laboratory range.
- •6) Adequate hematologica,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) Major surgery within the previous 2 weeks;
- •12) Radiotherapy within the previous 4 weeks;
- •13) Any significant toxicity from prior chemotherapy;
- •14) Unreliability or inability to follow protocol requirements
- •15) Potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period
- •16) Pregnancy
研究者
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