JPRN-UMIN000016138已完成未知
A Randomized, Open Label, Phase II Trial of Bevacizumab Plus Weekly Paclitaxel Followed by Bevacizumab Monotherapy Maintenance Versus Weekly Paclitaxel Followed by Observation in Patients With Relapsed Ovarian Sex-cord Stromal Tumours - Efficacy and Safety of Bevacizumab (Avastin) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours
ARCAGY/ GINECO GROUP0 个研究点目标入组 60 人开始时间: 2015年1月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1.Prior systemic therapy with bevacizumab 2.Active peripheral neuropathy >= grade 3 (NCI-CTCAE v4.3) 3.Prior history of other malignancies other than ovarian SCST unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer 4.No resolution of specific toxicities related to any prior anti-cancer therapy to grade <=1, excluding alopecia, according to the NCI-CTCAE v.4.3 5.History or evidence of thrombotic or hemorrhagic disorders or transient ischemic attack or sub-arachnoids' haemorrhage within 6 months prior to first dose of study drugs 6.Uncontrolled arterial hypertension despite optimal antihypertensive therapy or clinically significant cardiovascular disease 7.History of bowel obstruction, including sub-occlusive syndrome and history of abdominal fistula, gastro-intestinal perforation or intra-abdominal abscess during the year prior to inclusion 8.Prior treatments: 1)Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study 2)Another investigational drug within 30 days of first study treatment dosing 3)Chronic use of aspirin> 325 mg/day or use of any other inhibitor of platelet aggregation 4)Chronic treatment with non steroids anti-inflammatory agents 5)Intake of granulocyte growth factor within 3 weeks before study entry 9.Treatment during the study: 1)Debulking surgery prior to disease progression is not foreseen 2)Concurrent radiotherapy during the study treatment 10.Presence of hematuria and proteinuria >= 2+ (urine dipstick). 11.Untreated evolutive brain metastases 12.Active bacteria or fungal infection 13.Known HIV1, HIV2 or chronic hepatitis B or C infection 14.Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies 15.Any contraindications to paclitaxel treatment: for example severe hypersensitivity reactions to paclitaxel or to any of the excipients
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