JPRN-jRCTs031180244
已完成
2 期
An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant recurrent ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer - JGOG3023
Shoji Tadahiro0 个研究点目标入组 103 人2019年3月14日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- platinum-resistant recurrent ovarian cancer
- 发起方
- Shoji Tadahiro
- 入组人数
- 103
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
The efficacy of BBP(bevacizumab beyond progressive) in platinum-resistant recurrent ovarian cancer using bevacizumab as pretreatment has been proven, and the prognosis is expected to be improved.
研究者
入排标准
入选标准
- •1\.Patients histologocally confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- •2\.Patients must have platinum\-resistant disease (defined as progression within \<6 months from completion of a minimum of 3 platinum therapy (including Bevacizumab) cycles. (Assessment for disease progression by tumor marker alone is not accepted.)
- •3\.Patients \>\= 20 years of age.
- •4\.ECOG Performance Status: 0\-2
- •5\.Patients can be included if they have a RECIST progression, with either measurable or non\-measurable disease. Patient who can be evaluated based on GCIG CA125 criteria(The value of CA 125 within 2 weeks before treatment \>\= twice the upper limit of hospital reference value) is allowed.
- •6\.Life expectancy of \>\= 90 days.
- •7\.Signed informed consent obtained prior to initiation of any study\-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
- •8\.Adequate following organ function.
- •a.Neutrophils count \>\= 1,500 /mm3
- •b.Platelet count \>\= 10\.0x10000 /mm3
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). However 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.
结局指标
主要结局
未指定
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