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 人开始时间: 2019年3月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
研究概览
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
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
- •c.Hemoglobin >= 9.0 g/dL (Transfusion to maintain >= 9.0 g/dL acceptable)
- •d.Total bilirubin < 1.2 mg/dL
- •e.AST, ALT < 100 IU/L (For patients with liver meatstasis, < 200 IU/L)
- •f.Serum creatine =< 1.5 mg/dL
- •g.Proteinuria =< 1+ (>= 2 +: Confirm that =< 1.0 g in 24 hour urine collection or =< 1.0 the protein / creatinine ratio (UPC ratio) of occasional urine.)
- •h.PT-INR max. =< 1.5(However, while taking warfarin
- •1.5 =< PT-INR =< 2.5)
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.
- •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.
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