A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 467
- 主要终点
- Percentage of Participants Who Died Assessed From Point of Randomization
研究概览
简要总结
This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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;
- •histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease;
- •ECOG performance status of 0-1.
排除标准
- •local, or locally advanced, pancreatic cancer;
- •prior systemic treatment for metastatic pancreatic cancer;
- •<=6 months since last adjuvant chemotherapy;
- •other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.
研究组 & 干预措施
Gemcitabine, Erlotinib Standard Dose
Participants received erlotinib, 100 milligrams (mg), orally (PO), once daily until disease progression or unacceptable toxicity. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
干预措施: Gemcitabine (Drug)
Gemcitabine, Erlotinib Standard Dose
Participants received erlotinib, 100 milligrams (mg), orally (PO), once daily until disease progression or unacceptable toxicity. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
干预措施: Erlotinib, standard dose (Drug)
Gemcitabine, Erlotinib Escalating Dose
Participants received erlotinib, beginning at 150 mg/day, PO, once daily, and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal. Participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
干预措施: Erlotinib, escalating dose (Drug)
Gemcitabine, Erlotinib Escalating Dose
Participants received erlotinib, beginning at 150 mg/day, PO, once daily, and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal. Participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Percentage of Participants Who Died Assessed From Point of Randomization
时间窗: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
OS Assessed From Point of Randomization
时间窗: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.
次要结局
- Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST(BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.)
- Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In(BL and weekly thereafter for up to 46 months.)
- OS Assessed From Start of 4-Week Run-In(BL and weekly thereafter for up to 46 months.)
- Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization(Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.)
- PFS Assessed From Point of Randomization(Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.)
- Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST(BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.)
- Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST(BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.)
- Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In(BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.)
- PFS Assessed From the Start of 4-Week Run-In(BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.)