An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial- - JGOG3023

Japanese Gynecologic Oncology Group0 个研究点目标入组 103 人开始时间: 2015年4月22日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Japanese Gynecologic Oncology Group
入组人数: 103

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

We investigated the efficacy and safety of further bevacizumab therapy in platinum-resistant ovarian cancer patients whose disease had progressed after bevacizumab plus chemotherapy. Bevacizumab was effective beyond progressive disease and AEs were manageable. (The 58th Annual Meeting of Japan Society of Clinical Oncology)

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: Female

入选标准

未提供

排除标准

•1.Patient with ovarian borderline malignant tumor.2.History of other clinically active malignancy within 5 years of enrollment,3.Previous treatment with >= 4 anticancer regimens.4.History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.5.Surgery within 28 days prior to the start of study, or anticipation of the need for major surgery during study treatment.6.Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day) or clopidogreln (of more than 75 mg/day).prophylactic use of anticoagulations is allowed.7.Palliative radiotherapy < 14 days prior to anticipate in this study.8.LVEF defined by MUGA/ECHO below 50% (only applicable for patients intended to be treated with pegylated liposomal doxorubicin).9.Pre-existing peripheral neuropathy >=CTC grade 2 for those patients planned to receive paclitaxel.10.Symptomatic CNS metastasis.11.Pregnant or lactating females. or Women of childbearing potential not using highly-effective contraception.12.Patient having the following conditions: a.History or evidence of thrombotic or hemorrhagic disorders. b.New York Heart Association (NYHA) grade II or greater congestive heart failure(CHF) c.serious cardiac arrhythmia requiring medication d.Uncontrolled hypertension e.Non-healing wound, ulcer or bone fracture. f.HBsAg(+), HBcAb and/or HBsAb(+)and >=2.1 log copies/ml of HBV-DNA levels, or HIV(+).13.Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study.14.Known hypersensitivity to any of the study drugs or excipients.15.Patient who is judged inappropriate to participate in this study by the principle investigator.

研究者

发起方

Japanese Gynecologic Oncology Group

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进行中（未招募）

不适用

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