A Phase II, Open Label Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 9
- 主要终点
- Percentage of Participants Surviving at 6 Months
研究概览
简要总结
The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.
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
- •Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease)
- •Participants must have measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
- •Participants must not have received prior chemotherapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer
- •Karnofsky performance status (KPS) of 70-100
- •Adequate hematologic, hepatic and renal function
排除标准
- 未提供
研究组 & 干预措施
Ixabepilone plus Cetuximab
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
干预措施: Ixabepilone (Drug)
Ixabepilone plus Cetuximab
All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
干预措施: Cetuximab (Drug)
结局指标
主要结局
Percentage of Participants Surviving at 6 Months
时间窗: From time of first dose of study drug through 6 months
The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.
次要结局
- Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression(Baseline)
- Best Overall Tumor Response(From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression))
- Percentage of Participants With Objective Tumor Response(From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)
- Median Progression Free Survival Time(From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)
- Median Overall Survival Time(From the first dosing date until death (last reported death was 21 months after first dose).)
- Median Duration of Response(From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).)
- Median Time to Response(Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.)
- Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)(From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.)
- Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)(From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.)
- Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)(From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.)
- Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption(From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.)
- Change From Baseline in FHSI-8 Total Score by Time-point(Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study))