Pemetrexed Alone as Salvage Treatment in Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
试验速览
- 阶段
- 2 期
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
Pemetrexed is an anticancer agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication. In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.Pemetrexed is used as a standard therapeutic agent for lung cancer, pleural mesothelioma, peritoneal mesothelioma.In addition to these effective anti-cancer effect, Pemetrexed is not severe side effects of the medicine.
Pemetrexed has been research in colon cancer. Zhang, etc., demonstrated the anti-cancer effect of Pemetrexed in human colon cancer Cells.
Although sometimes made also two or more clinical studies, Pemetrexed was reported 15-17% of the treatment response rate in these two studies.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 20 years of age.
- •Written and voluntary informed consent understood, signed and dated.
- •They must have refractory or progressive colorectal cancer for which there is no further curative therapy available.
- •Subject able to adhere to the study visit schedule and other protocol requirements.
- •At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
- •Must have a life expectancy of 3 months or more
- •Demonstrate adequate organ function
- •Negative urine or serum pregnancy test within 28 days of study treatment
- •Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.
排除标准
- •History of malignancy in the last 5 years.
- •Subject has known historical or active infection with HIV, hepatitis B, or hepatitis C.
- •Breast-feeding or pregnant female
- •Patients can not the administration of Folic acid or Vitamin B
- •Before treatment with Pemetrexed.
- •Patients who can not swallow oral medication.
- •The most recent treatment with the clinical trial for the drug for 14 days prior to enrollment.
- •Systemic chemotherapy within three weeks after the administration of the last before the test treatment, radiation therapy patients who had been administered.
- •Except for the hair loss, it is induced before cancer treatment, all of toxicity in progress (> CTCAE1 grade).
- •Upper GI bleeding within registration before 4 weeks of Bowel obstruction or CTCAE3 or 4 grade.
- •Subject who experienced a recent myocardial infarction, including severe/unstable angina pectoris, coronary/peripheral artery bypass graft, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, significant or uncontrolled cardiovascular disease CHF, and cerebrovascular accident or transient ischemic attack, or seizure disorder in the past year.
研究组 & 干预措施
Pemetrexed
Pemetrexed 500 mg/m2 IV Q 3 weeks
干预措施: Pemetrexed (Drug)
结局指标
主要结局
overall response rate
时间窗: 2 years
次要结局
- progression free survival(2 years)
- overall survival(2 years)
- Number of subjects with Adverse Events as a measure of safety and Tolerability(2 years)
研究者
Seung tae Kim,PhMD
MD,PhD,Division of hematology-oncology,Department of medicine
Samsung Medical Center