A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Percentage of Participants With Progression-free Survival (PFS)
研究概览
简要总结
This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated time on study treatment was until disease progression, and the target sample size was <100 individuals.
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
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, ≥ 18 years of age;
- •advanced or metastatic liver cancer;
- •≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.
排除标准
- •prior or concomitant systemic anti-cancer treatment for advanced disease;
- •patients at high risk of variceal bleeding;
- •clinically significant cardiovascular disease;
- •major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.
研究组 & 干预措施
bevacizumab + erlotinib
Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
干预措施: bevacizumab (Avastin) (Drug)
bevacizumab + erlotinib
Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
干预措施: erlotinib (Tarceva) (Drug)
结局指标
主要结局
Percentage of Participants With Progression-free Survival (PFS)
时间窗: Week 16
Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug. Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
次要结局
- Time to Tumor Progression(Event driven (median follow-up 12 months))
- Progression-free Survival (PFS)(Event driven (median follow-up 12 months))
- Overall Survival (OS)(Event driven (median follow-up 12 months))
- Overall Response Rate (ORR)(Event driven (median follow-up 12 months))
- Disease Control Rate (DCR)(Event driven (median follow-up 12 months))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 107 Weeks)