NCT00407563已完成2 期
A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma
Accelerated Community Oncology Research Network22 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 22
- 主要终点
- 6-month Progression-Free Rate
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Measurable disease by CT or MRI.
- •At least 1 "target lesion" to be used to assess response as defined by GOG RECIST criteria.
- •ECOG performance status of 0 or
- •Patient provides voluntary written informed consent.
- •At least 18 years of age.
- •Negative serum pregnancy test.
- •Recovered from any recent surgery for at least 30 days and is free of active infection.
- •Received the following prior therapy at time of enrollment:
- •Must have had 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin or organoplatinum. Initial therapy may have included high-dose therapy, consolidation, or extended therapy. Patient should be defined as recurrent or progression of disease within 6 months of last platinum chemotherapy.
- •May have had 1 additional cytotoxic or non-cytotoxic chemotherapy regimen.
- •Must have adequate hematologic and hepatic function.
排除标准
- •Previously received bevacizumab.
- •History of other invasive malignancy with the exception of nonmelanoma skin cancer.
- •ECOG performance status of 2, 3, or
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study. Patient must be bevacizumab naïve.
- •Blood pressure of >150/100 mm Hg on antihypertensive medications.
- •Prior history of hypertensive crisis or hypertensive encephalopathy.
- •Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure.
- •History of myocardial infarction within 6 months of enrollment.
- •History of stroke or transient ischemic attack within 6 months prior to study enrollment.
- •Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection)or symptomatic peripheral vascular disease.
- •Bleeding diathesis or coagulopathy.
- •Presence of CNS or brain metastases.
- •Pre-existing peripheral neuropathy of Grade ≥
- •A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
- •A partial or complete small or large bowel obstruction demonstrated radiologically within 3 months prior to study enrollment.
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
- •Positive pregnancy test or is lactating.
- •History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
- •Serious, non-healing wound, ulcer, or bone fracture.
- •Serious intercurrent medical or psychiatric illness, including serious active infection.
- •Inability to comply with study and/or follow-up procedures.
- •Life expectancy of less than 12 weeks.
- •Proteinuria at screening as demonstrated by either:
- •Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR
- •Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
- •Known hypersensitivity to any component of bevacizumab.
结局指标
主要结局
6-month Progression-Free Rate
时间窗: 6 months after initiation of study treatment
Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
次要结局
- Best Overall Response(Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.)
- Overall Survival(Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.)
- Progression-free Survival (PFS)(PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.)
- Best Overall Response at Six Months(Assessed over 6 months of study treatment)
研究者
研究点 (22)
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