A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
研究概览
简要总结
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •metastatic colorectal cancer
- •at least 1 measurable lesion according to RECIST v. 1.1
- •patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
- •disease progression </= 8 weeks after last dose of Avastin
- •ECOG </=2
- •No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line treatment with XELOX or FOLFOX + Avastin
排除标准
- •disease progression > 8 weeks after last Avastin administration
- •clinically significant cardiovascular disease
- •CNS disease except for treated brain metastasis
- •history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
- •major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
研究组 & 干预措施
Avastin (bevacizumab) + standard of care
干预措施: bevacizumab [Avastin] (Drug)
Avastin (bevacizumab) + standard of care
干预措施: fluorouracil (5FU) (Drug)
Avastin (bevacizumab) + standard of care
干预措施: leucovorin (Drug)
Avastin (bevacizumab) + standard of care
干预措施: capecitabine [Xeloda] (Drug)
Avastin (bevacizumab) + standard of care
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
时间窗: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.
次要结局
- PFS From the Start of First-Line Therapy(Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months)
- Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)(Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months)
- Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression(Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months)