Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.
详细描述
This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen
- •must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line)
- •must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral CT) OR elevated CA-125 (> 100 on two occasions at least one week apart
- •performance status greater than or equal to 70%
排除标准
- •prior treatment with anti-angiogenesis agent
- •treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)
- •evidence of other malignancy within 3 years of study enrollment
- •history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation
- •history of intra-abdominal abscess with 6 months prior to day 0
- •pregnant or lactating patients
研究组 & 干预措施
Treatment
Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
干预措施: Topotecan (Drug)
Treatment
Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.
次要结局
- Objective Response Rate(Response)
- Number or Participants With Toxicity(measured at each treatment cycle)
- Evaluation of Overall Survival(PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.)
研究者
Beth Edelheit
Thomas Malpass, MD, Kathryn McGonigle, MD
Benaroya Research Institute