NCT00930891已完成2 期
Randomized Phase II-III Study of Bevacizumab 7,5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy : PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide)
Intergroupe Francophone de Cancerologie Thoracique60 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2009年9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
- 143
- 试验地点
- 60
- 主要终点
- Response rate (complete response + partial response)
研究概览
简要总结
Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive regimens remain controversial and recent attempts at increasing dose-intensity have been restricted to patients with a more favourable presentation.
Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial Growth Factor). In association with double-drug standard chemotherapies, it has been proven that bevacizumab can improve survival of previously untreated advanced non-small-cell lung cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on NSCLC deserve to be tested on small-cell lung cancers.
In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Non-Small-Cell Lung Cancer or mixed cancer (small-cell / non-small-cell)
- •Previous antitumoral treatment of the small-cell lung cancer (chemotherapy, radiotherapy, immunotherapy, surgery)
- •Non-extended disease as defined by VALG
- •Natremia < 125 mmol/L
- •Hypercalcemia whereas a corrective treatment
- •Pathology contra-indicating the hyper-hydration
- •Hemoptysis in the last three months
- •Tumor invading large vessels or invading the proximal trachea-bronchial tree (visible at the medical imagery). Investigator or radiologist must reject tumors adjoining, merging or extending to large vessel's lumen (for example : pulmonary artery, superior vena cava)
- •Symptomatic cerebral or meningeal metastasis
- •Other cancer in progress or medical history of cancer in the five last years (excepted basal cell carcinoma or in situ cervical cancer of the uterus.
- •Important surgical intervention (including surgical biopsy), traumatic lesion during 28 days before starting the treatment, or anticipation of an important surgical intervention during the study
- •Minor surgical intervention, including implanting permanent catheter during the 24 hours before the first administration of bevacizumab
- •Unhealed wound, evolutive gastroduodenal ulcer, fractured bone
- •Medical history of abdominal fistula, trachea-oesophageal fistula, of another type with a severity rank of 4, gastrointestinal perforation or intraabdominal abscess during 6 month before inclusion
- •Ongoing or recent use of aspirin (during 10 days before the first administration of bevacizumab) (>325 mg/day) or use of another platelet aggregation inhibitor (dipyridamole, ticlopidine, clopidogrel > 75 mg/day), or ongoing or recent use of a therapeutic dose (during 10 days before the first administration of bevacizumab) of anticoagulant or thrombolytic drugs per os or in parenteral injection. Prophylactic use of anticoagulant drug is allowed
- •Medical history or genetic predisposition to bleeding or coagulopathy
- •Clinically significative cardiac disease: infarct or CVA during 6 month before inclusion, unstable angina, congestive cardiac failure level > II as defined by New York Heart Association (NYHA) or cardiac arrythmia needing a specific treatment which risk to interfere with the study, or uncontrolled arrythmia.
- •Known allergy or hypersensibility to monoclonal antibodies (bevacizumab), to chinese hamster ovary cells or to any humanized or recombinant antibody
- •Uncontrolled high blood pressure (systolic pressure > 150 mm Hg and/or diastolic pressure > 100 mm Hg), with or without hypotension treatment. Patients presenting an high blood pressure are eligibles if their treatment can decrease their blood pressure to the values required by the protocol.
- •Severe ongoing infectious disease or fever > 38.5°C or evidence of any other pathology, organic or neurologic functions deterioration, physical examination or laboratory result which cause suspicion of a disease which contra-indicate use of any studied treatment.
- •Woman with a positive pregnancy test or who has not made a pregnancy test (unless pregnancy risk can be excluded)
- •Lactating woman
- •Sexually active woman who don't use hormonal or mechanical contraceptive method or sexually active man who has a sexually active partner who don't want to use an effective contraceptive method during the course of the study and during the 6 months after last treatment administration
- •Patient who as already been included and treated in the present study
- •Patient who participate or who has participated in another study during 4 weeks before treatment administration
- •Patient who receive a previous antiangiogenic treatment (experimental or commercial : bevacizumab, thalidomide, CP-547632, sunitinib, sorafenib...)
- •Geographical or psychological condition which not allowed a good comprehension or compliance to protocol
- •Liberty deprived patient
研究组 & 干预措施
Arm A
Active Comparator
4 additional cycles of chemotherapy
干预措施: Standard Chemotherapy (PCDE or PE) (Drug)
Arm A
Active Comparator
4 additional cycles of chemotherapy
干预措施: Prerandomization Chemotherapy (PCDE or PE) (Drug)
Arm B
Experimental
4 additional cycles of chemotherapy + bevacizumab
干预措施: Experimental Treatment (PCDE or PE + bevacizumab) (Drug)
Arm B
Experimental
4 additional cycles of chemotherapy + bevacizumab
干预措施: Prerandomization Chemotherapy (PCDE or PE) (Drug)
结局指标
主要结局
Response rate (complete response + partial response)
时间窗: 6 weeks after randomization
次要结局
- Progression-free survival(12 weeks)
- Complete response length(12 weeks)
- Quality of life(12 weeks)
- Toxicities(12 weeks)
研究者
研究点 (60)
Loading locations...
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