A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel With Bevacizumab as First Line Therapy in Patients With FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Twelve-month Progression-free Survival (PFS) Rate in Participants
研究概览
简要总结
Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).
详细描述
Participants were
- administered study medication approximately 28 days after initial surgery for ovarian cancer
- received the study treatment regimen of up to one year unless there was disease progression, unacceptable toxicity, death, participant refusal, or treatment delay beyond the time frame permitted for each treatment
Participants were followed for survival for a minimum 3 years from the date of enrollment
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oxaliplatin/Docetaxel/Bevacizumab
Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
干预措施: Bevacizumab (Avastin®) (Drug)
Oxaliplatin/Docetaxel/Bevacizumab
Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
干预措施: Docetaxel (Taxotere®) (Drug)
Oxaliplatin/Docetaxel/Bevacizumab
Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
干预措施: Oxaliplatin (Eloxatin®) (Drug)
结局指标
主要结局
Twelve-month Progression-free Survival (PFS) Rate in Participants
时间窗: up to 12 months following treatment initiation
Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: * appearance of a new lesion * symptomatic deterioration * progression of target or nontarget lesions * death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.
次要结局
- Twenty Four-month Progression-free Survival (PFS) Rate in Participants(up to 24 months following treatment initiation)
- Median Time to Progression-free Survival (PFS)(up to approximately 1300 days following treatment initiation)
- Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)(up to 12 months following treatment initiation)
- Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline(up to 12 months following treatment initiation)
- Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline(up to approximately 1500 days following treatment initiation)
- CA-125 Response Rate(up to 12 months after treatment initiation)
- Overall Survival Rate(up to up to approximately 1700 days after treatment initiation)
- Median Overall Survival Time(up to approximately 1700 days after treatment initiation)