EUCTR2013-001322-26-CZ进行中（未招募）1 期
A randomized, open-label, three-arm, multi-center Phase II clinical trial evaluating effect of addition of DCVAC/OvCa to first line standard chemotherapy (carboplatin and paclitaxel) in women with newly diagnosed epithelial ovarian carcinoma
SOTIO a.s.0 个研究点目标入组 120 人开始时间: 2013年8月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •1.Female aged =18 years
- •2.Patients with newly diagnosed, histologically confirmed, FIGO (Féderation Internationale de Gynécologie et d’Obstétrique) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
- •3.Optimally debulked (zero residuum) or maximal residuum <1cm
- •4.Laboratory criteria:
- •?White blood cells (WBC) >4,000/mm3 (4.0 x109/L)
- •?Neutrophil count >1,500/mm3 (1.5 x109/L)
- •?Hemoglobin (Hb) =10g/dL (100g/L)
- •?Platelet count =100,000/mm3 (100 x109/L)
- •?Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g. Gilbert´s syndrome are permitted)
- •?Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2x upper limit of normal (ULN), serum creatinine =2.0mg/dL
- •?Blood Urea Nitrogen (BUN) <2.0x ULN
- •5.Adequate coagulation parameters
- •?Activated partial thromboplastin time (APTT) =1.5x ULN and
- •?International Normalized Ratio (INR) = 1.5
- •?Post-operative treatment with low molecular weight heparin (LMWH) is acceptable
- •6.Life expectancy of at least 12 months based on Investigator’s judgment
- •7.Eastern Cooperative Oncology Group (ECOG) Performance status 0?2
- •8.Signed informed consent including patient’s ability to comprehend its contents
- •9.Females of childbearing potential (assessed by Investigator) must have had a negative serum pregnancy test at screening (ß human chorionic gonadotropin [ß-HCG])
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1.FIGO I,II,IV epithelial ovarian cancer
- •2.FIGO III clear cells epithelial ovarian cancer
- •3.Non-epithelial ovarian cancer, borderline tumors
- •(tumors of low malignant potential)
- •4.Post-surgery residual disease with lesion(s) >1cm
- •5.Prior or current systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy [bevacizumab], tyrosine kinase inhibitor therapy, vascular endothelial growth factor [VEGF] therapy or hormonal therapy)
- •6.Previous or concurrent radiotherapy to the abdomen and pelvis
- •7.Malignancy other than epithelial ovarian cancer, except those that have been in CR for a minimum of 3 years, or incidental low-grade carcinoid which has been totally extirpated during primary debulking surgery without signs of distant metastasis, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
- •8.Patient co-morbidities:
- •?Human immunodeficiency virus (HIV) positive, human T lymphotropic virus (HTLV) positive
- •?Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
- •?Evidence of active bacterial, viral or fungal infection requiring systemic treatment
- •?Clinically significant cardiovascular disease including:
- •oSymptomatic congestive heart failure
- •oUnstable angina pectoris
- •oSerious cardiac arrhythmia requiring medication
- •oUncontrolled hypertension
- •oMyocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) <40% or serious cardiac conduction system disorders, if a pacemaker is not present
- •?Pericardial effusion of any National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade
- •?Peripheral neuropathy having a CTCAE =Grade 2
- •?Active autoimmune disease requiring treatment
- •?History of severe forms of primary immune deficiencies
- •?History of anaphylaxis or other serious reaction following vaccination
- •?Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial
- •9.Known hypersensitivity to any constituent in the DCVAC/OvCa
- •10.Systemic immunosuppressive therapy for any reason
- •11.Refusal to sign the informed consent
- •12.Participation in a clinical trial using experimental therapy within the last 4 weeks prior study entry
- •13.Fertile woman of childbearing potential not willing to use highly effective method of contraception or combination of methods resulting into PEARL Index < 1 (implants, injectables, combination of oral contraceptives with intrauterine devices or barrier method of contraception or spermicidal jelly, vasectomized / sterilized partner or sexual abstinence) for the study duration and at least six months afterwards
- •14.Pregnant or lactating women
研究者
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