NCT01303497已完成2 期
Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced Angiosarcomas Not Accessible to Surgery Treatment.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Progression free rate after 6 months of treatment
研究概览
简要总结
Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
详细描述
Randomization is stratified :
- angiosarcoma in irradiated region : yes / no
- visceral angiosarcoma : yes / no
All patient will received a maximum of 6 cycles of weekly Paclitaxel (Arm A and B) in association or not with Bevacizumab (ArmB).
1 cycle = 28 days Treatment by Bevacizumab is to continue beyond the 6th cycle, until disease progression or unacceptable toxicity
Arm A and B:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiosarcoma histologically proven
- •Metastatic or locally advanced and not accessible to surgery treatment
- •Measurable tumor with at least 1 measurable lesion, according to RECIST
- •For angiosarcoma in irradiated region, absence of clinical arguments of progression of the tumor prior treated by radiation
- •At least 28 days since the previous treatment (systemic or major surgery)
- •Performance Status (ECOG) ≤ 1
- •Man or woman >= 18 years
- •Polynuclear neutrophils >1500/mm3, platelets > 100 000/ mm3, Hemoglobin > 9.0 g/dl
- •Total bilirubin ≤ 1.5 x USL, AST and ALT ≤ 2.5 x USL (or ≤ 5 if hepatic metastasis )
- •Serum creatinin ≤ 1.5 x USL or clearance calculated > 50 ml/mn (Cockcroft formulae)
- •Absence of hematuria on dipstick
- •Proteinuria on dipstick <2+, if >2, the 24 hours proteinuria must be < 1g
- •Albumin > 35 g/l and lymphocytes > 700/mm3 attesting a life expectancy > 3 months
- •Normal cardiac function : LVEF ≥ 50%
- •Normal coagulation test : INR ≤ 1.5 and TCA ≤ 1.5 x USL within 7 days before inclusion
- •Systolic BP ≤ 150 mmHg and diastolic BP ≤ 100 mmHg
- •Negative pregnancy test for women of reproductive potential(within 7 days before treatment start)
- •Effective contraceptive methods for male and female (if applicable) during the period of treatment and until the 6 months after the last administration of Bevacizumab
- •Adequate central veinous access
- •Patient covered by government health insurance
- •Informed consent form signed by the patient
排除标准
- •Patients that have received more than 2 regimens of chemotherapy whatever the indication
- •Kaposi's sarcoma, hemangio-endothelioma, hemangio-pericytoma (Malignant solitary fibrous tumor)
- •Surgery (except the diagnostic biopsy) or radiotherapy within the past 4 weeks before inclusion, except antalgic radiotherapy
- •Uncontrolled, active peptic ulcer,
- •Other malignant evolutive tumor
- •Previous thrombotic or hemorrhagic disorders
- •Clinically significant cardiovascular disease (stroke within 6 months prior inclusion, unstable angina, heart failure, myocardial infarction, arrhythmia requiring treatment)
- •Anticoagulant treatment for curative aim within 10 days before beginning of treatment (oral or parenteral administration), aspirin > 325 mg/day, or Plavix or a thrombolytic (thrombolytics for preventive use is permitted) or anti-platelet (dipyridamol, ticlopidine, clodiprogel, cilostazol)
- •Chronic treatment(more than 15 days) by every AINS including aspirin > 325 mg/j
- •Currently active bacterial or fungus infection (grade > 2 CTCAE v4.02)
- •Known HIV1, HIV2, hepatitis B or hepatitis C infections
- •Presence of known meningeal or brain metastasis
- •Epilepsy requiring the use of anti-epileptic
- •Previous organ transplant
- •Peripheral stem cell transplantation within 4 months prior to inclusion in the study
- •Using of drugs affecting the biological response, for example G-CSF, within the 3 weeks before inclusion
- •Kidney dialysis patient
- •Clinically significant neuropathy (grade> 2 CTCAE V4.02)
- •Any circumstance that could jeopardise compliance or proper follow-up during the trial
- •Pregnant or nursing women. Women should not breastfeed for at least 6 months after the last administration of Bevacizumab
- •Constitutional or acquired coagulopathy
- •Uncontrolled hypertension (SBP> 150 mmHg or DBP> 100 mmHg)
- •Known hypersensitivity to paclitaxel or to one of its excipients (Cremophor EL, to Bevacizumab components, to products of Chinese hamster ovary cells (CHO) or other recombinant human or humanized antibodies
- •Patients unable to undergo trail medical follow-up for geographical, social or psychological reasons
- •Patient refusal of ambulatory care
研究组 & 干预措施
Arm B : Paclitaxel + Bevacizumab
Other
administration of paclitaxel drug during per cycle of 28 days (6 cycles Max) + Bevacizumab every two weeks during paclitaxel cycles then every 3 weeks during P cycles until disease progression or inacceptable toxicity
+ blood sample on day 1, 8, 15, 29 and 57
干预措施: Paclitaxel (Drug)
Arm A : Paclitaxel
Other
administration of paclitaxel drug during cycle of 28 days (6 cycles Max) + blood sample on day 1, 8, 15, 29 and 57
干预措施: Paclitaxel (Drug)
Arm B : Paclitaxel + Bevacizumab
Other
administration of paclitaxel drug during per cycle of 28 days (6 cycles Max) + Bevacizumab every two weeks during paclitaxel cycles then every 3 weeks during P cycles until disease progression or inacceptable toxicity
+ blood sample on day 1, 8, 15, 29 and 57
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression free rate after 6 months of treatment
时间窗: after 6 months of treatment
Stable disease, complete response and partial response according to RECIST 1.1
次要结局
- Global median survival(an average time period of 18 months)
- Median progression-free rate(an average time period of 1 year)
- Correlation between efficacity and serum expression of anti angiogenic factors(Day 1, 8, 15, 29 and 57)
- Tolerance(during the study)
- Correlation between efficacity and beta-tubuline III expression in tissue(At baseline)
- Objective response at 3, 6, 9 months of treatment(at 3, 6, 9 months of treatment)
研究者
研究点 (13)
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