A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine.
In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.
详细描述
This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.
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
- •Histologically confirmed adenocarcinoma of the pancreas
- •Prior treatment for distant or locally advanced disease with gemcitabine-based therapy
- •Measurable or evaluable disease
- •ECOG performance status 0-2
- •Adequate hematological parameters
- •Adequate baseline liver function
- •At least 28 days from any major surgery
- •At least 2 weeks from the last radiation treatment
- •Must have recovered from reversible toxicities of prior chemotherapy
- •Must be able to discontinue any nonsteroidal anti-inflammatory medications
- •Must be willing to receive intramuscular vitamin B12 shots and take oral folate supplements
排除标准
- •Any prior treatment with pemetrexed
- •More than one prior chemotherapy regimen
- •HIV positive on antiretroviral therapy
- •Pregnant or lactating
- •Prior organ allograft
- •On concurrent antitumor therapy including radiation therapy or other chemotherapies
- •Creatinine clearance 45 ml/min or less
- •Absolute neutrophil count < 1500
- •Platelets < 75,000
- •Bilirubin > 1.5 times the upper limit of normal
- •Transaminases > 3 times the upper limit of normal except in known liver metastasis wherein they may be </= 5 times upper limit of normal
- •Clinically significant ascites or pleural effusion that cannot be drained
- •Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
研究组 & 干预措施
chemotherapy
pemetrexed
干预措施: pemetrexed (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 6 months after last patient enrolled
Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.
次要结局
- Objective Response(Within two months of the completion of the last dose of chemotherapy)
- Number of Participants With Adverse Events(30 days after last dose of study drug)
- CA 19-9 Response(Within two months of the last dose of chemotherapy)
研究者
Jimmy Hwang
Principal Investigator
Georgetown University