An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive Advanced/Metastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- Progression-Free Survival (PFS) - Percentage of Participants With an Event
研究概览
简要总结
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, 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;
- •well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
- •no previous anti-cancer therapy, other than surgery;
- •progressive metastatic disease;
- •>=1 measurable lesion.
排除标准
- •abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
- •patients with known bleeding disorders;
- •unstable systemic disease;
- •chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
- •previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: 5 FU (Drug)
1
干预措施: Streptozotocin (Drug)
2
干预措施: bevacizumab [Avastin] (Drug)
2
干预措施: Xeloda (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) - Percentage of Participants With an Event
时间窗: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
PFS - Time to Event
时间窗: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.
PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
时间窗: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
次要结局
- Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)(Screening, every 3 months during treatment)
- OS - Time to Event(Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years)
- Duration of ODC - Time to Event(Screening, every 3 months during treatment, every 6 months during follow-up to 2 years)
- Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months(Screening, every 3 months during treatment, every 6 months during follow-up to 2 years)
- Percentage of Participants With a Response by Best Overall Response(Screening, every 3 months during treatment, every 6 months during follow-up to 2 years)
- Duration of Overall Response (OR) - Percentage of Participants With an Event(Screening, every 3 months during treatment, every 6 months during follow-up to 2 years)
- Duration of OR - Time to Event(Screening, every 3 months during treatment, every 6 months during follow-up to 2 years)
- EORTC QLQ-C30 Functional and Symptom Scale Scores(Screening, every 3 months during treatment)
- Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months(Screening, every 3 months during treatment, every 6 months during follow-up to 2 years)
- Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event(Screening, every 3 months during treatment, every 6 months during follow-up to 2 years)
- Overall Survival (OS) - Percentage of Participants With an Event(Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years)
- OS - Percentage of Participants Surviving at 12 and 24 Months(Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years)
- Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category(Screening, every 3 months during treatment)