Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 41
- 主要终点
- Survival after 6 months of treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with pemetrexed disodium may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with pemetrexed disodium to see how well it works in treating patients with unresectable or metastatic biliary tract or gallbladder cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed disodium in patients with unresectable or metastatic biliary tract or gallbladder cancer. (Phase I closed to accrual as of Oct. 2005.)
- Determine the 6-month survival rate of patients treated with this regimen.
- Determine the best objective tumor response rate and duration of best objective tumor response in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the individual patient variation in toxicity of and/or response to this regimen due to genetic differences in proteins involved in drug response in these patients.
OUTLINE: This is a multicenter phase I dose-escalation study of gemcitabine followed by a phase II study.
- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity (phase I closed to accrual as of October 2005).
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pemetrexed + gemcitabine
Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: gemcitabine hydrochloride (Drug)
pemetrexed + gemcitabine
Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: pemetrexed disodium (Drug)
结局指标
主要结局
Survival after 6 months of treatment
时间窗: Up to 6 months
次要结局
- Response as assessed by RECIST criteria every 8-16 weeks(Up to 16 weeks)
- Toxicity as assessed by CTC v3 every 4 weeks(Up to 4 weeks)