NCT01583322已完成2 期
Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum
ARCAGY/ GINECO GROUP36 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 36
- 主要终点
- Median Progression-free Survival (PFS) in each study arm
研究概览
简要总结
Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy.
In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing.
Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib).
This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First diagnosis of histological confirmed (cytology alone excluded) epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. Histology should be obtained by laparoscopy (or by laparotomy),
- •FIGO-Stages IIIC - IV,
- •ECOG performance status < 2,
- •Life expectancy of at least 6 months,
- •Primary debulking surgery denied and maximum surgical effort of cytoreduction with the goal of no residual disease planned as interval debulking surgery,
- •Interval between diagnosis and enrolment (informed consent) ≤ 8 weeks,
- •Adequate hepatic, renal and bone marrow functions:
- •Platelets > 100 000 /μL, Hemoglobin > 9.0 g/dL, Absolute Neutrophil Count (ANC) > 1500/μL, Prothrombin time and/or partial thromboplastin time < 50% deviation from normal limits in the absence of therapeutic anticoagulation, Proteinuria < CTCAE grade 2, Total bilirubin ≤ upper limit of normal (ULN), ALT and/or AST ≤ 2.5 x ULN, Glomerular filtration rate >40 mL/min,
- •Females, age 18 years or older,
- •Patient has given written informed consent,
排除标准
- •Histological diagnosis of malignant tumour of non-epithelial origin (e.g. germ cell tumour, malignant mixed mullerian tumour, sex cord-stromal tumour) of the ovary, the fallopian tube or peritoneum or borderline tumour of the ovary (tumour of low malignant potential),
- •Non-healing wound, ulcer (intestinal tract, skin) or bone fracture,
- •Clinical symptoms or signs of gastrointestinal obstruction,
- •History of major thromboembolic event, defined as:
- •Pulmonary embolism (PE) within 6 months prior to enrolment,
- •Recurrent pulmonary embolism (history of at least 2 events),
- •History of at least 2 unprovoked (without a transient or reversible risk factor) events of proximal deep venous thrombosis,
- •Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation, Prothrombin G20210A mutation),
- •Patients with perioperative thrombosis including proximal deep vein thrombosis (DVT) or thrombosis of visceral vessels not associated with pulmonary embolism may be included in the trial if stable therapeutic anticoagulation is documented,
- •Known inherited or acquired bleeding disorder,
- •Significant cardiovascular diseases, including:
- •Hypertension not controlled by medical therapy,
- •Unstable angina within the past 6 months,
- •History of myocardial infarction within the past 6 months,
- •Congestive heart failure > NYHA II,
- •Clinically relevant cardiac arrhythmia
- •Peripheral vascular disease Fontaine stage ≥3,
- •Clinically relevant pericardial effusion (e.g. pericardial effusion with echocardiographic or clinical signs of haemodynamic impairment),
- •History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months,
- •Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including HIV-infection, hepatitis B and/or C infection,
- •Poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy,
- •Clinical symptoms of brain metastases and/or diagnosis of brain metastases on imaging,
- •Pre-existing sensory or motor neuropathy CTCAE ≥ 2, except due to trauma,
- •Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug,
- •Other malignancy diagnosed within the past 5 years, except:
- •non-melanomatous skin cancer (if adequately treated),
- •cervical carcinoma in situ (if adequately treated),
- •carcinoma in situ of the breast (if adequately treated),
- •prior or synchronous endometrial cancer (if adequately treated), provided the following criteria are met:
- •Disease stage FIGO ≤ IB,
- •No more than superficial myometrial invasion,
- •Not poorly differentiated (less than grade 3, no papillary serous or clear cell histology),
- •Prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy),
- •Prior radiotherapy to the abdomen or prior radiotherapy to an extra-abdominal target volume that would bear the risk of increased toxicity of chemotherapy,
- •Hypersensitivity to Vargatef® (Nintedanib) and/or the excipients of the trial drugs,
- •Serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease, active ulcers (gastrointestinal tract, skin) or a laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study,
- •Patients with preserved reproductive capacity who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner) during the trial and for at least twelve months after end of active therapy,
- •Pregnancy or breast feeding,
- •Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule,
- •Active alcohol or drug abuse,
- •Any contraindications for therapy with paclitaxel or carboplatin, e.g. a history of severe hypersensitivity reactions to paclitaxel or platinum-containing compounds and their excipients, or other drugs formulated with Polyoxyl 35 Castor Oil - ELP,
- •Treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial.
研究组 & 干预措施
vargatef/Nintedanib
Experimental
干预措施: vargatef (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Median Progression-free Survival (PFS) in each study arm
时间窗: average of 18 months
次要结局
- Response rate(2 months after beginning of treatment)
研究者
研究点 (36)
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