NCT01109615终止2 期
Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with KRAS mutations.
研究设计
- 研究类型
- Interventional
- 干预模型
- Factorial
- 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 verified adenocarcinoma in colon or rectum
- •Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan.
- •KRAS mutation in primary tumour or metastasis.
- •Measurable disease according to RECIST
- •ECOG performance status 0, 1 or 2
- •Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment)
- •EDTA clearance: Uncorrected GFR > 45 ml/min.
- •Neutrophilocytes ≥1.5 x 10^9/l, leukocytes ≥3.0 x 10^9/l, thrombocytes ≥100x10^9/l
- •ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases).
- •Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research.
- •Fertile men and women (women <2 year after last menstruation) must use efficient birth control.
- •Signed informed consent.
排除标准
- •Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator.
- •Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix.
- •Other experimental treatment within 30 days prior to treatment start.
- •Pregnant or breastfeeding women.
- •Clinical or radiological signs of CNS metastases.
- •Planned radiation of target lesions.
- •Concurrent vaccination against yellow fever.
研究组 & 干预措施
Chemotherapy
Experimental
干预措施: Pemetrexed (Drug)
Chemotherapy
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Response rate
时间窗: Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months.
次要结局
- Progression free survival(Every 3 months until progression or death. Up to 12 months.)
- Overall survival(12 months.)
研究者
研究点 (1)
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