NCT00873353已完成2 期
An Open Non-randomized Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer
Grupo Gallego de Investigaciones Oncologicas8 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Objective response rate following RECIST criteria
研究概览
简要总结
The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.
详细描述
This efficacy will be determined by objective response rate following RECIST criteria.
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
- •Ability to understand and willingness to sign a written informed consent
- •Informed consent signed by the patient
- •Age > 18 years old
- •Able to fulfill all criteria from the protocol
- •Performance status Karnofsky ≥ 60% (ECOG 0-2)
- •Life expectancy ≥ 12 weeks
- •Histologically or cytological (excluding endocrine pancreatic tumour), with metastatic (stage IV), following 6th edition of TNM classification
- •Measurable disease following RECIST criteria
- •Adequate bone marrow function as determined by:
- •Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L
- •Platelets: ≥ 100 x 109/L
- •Hemoglobin: ≥ 9 g/dL.
- •Adequate liver function, as determined by:
- •Serum bilirubin (total): ≤ 1,5 x LSN
- •AST, ALT ≤ 2,5 x LSN in patients without liver metastasis. In patients with liver metastasis ≤ 5 x LSN
- •Adequate renal function, as determined by:
- •Clearance creatinine > 60.0 ml/min
- •Men or women potentially fertile (including postmenopausal women amenorrheic at least 24 months before the study) should use adequate contraceptive methods (oral contraceptives, intrauterine disposal, barrier methods together with spermicide or surgery sterilization)
排除标准
- •Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 6th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study.
- •Evidence of medullary compression, carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior inclusion.
- •Previous systemic treatment for metastasis pancreas cancer. Adjuvant chemotherapy is permitted ≥ 4 weeks prior de inclusion. All toxicities from the adjuvant treatment must been solve before the inclusion and should be confirmed the diseases progression (metastatic disease) alter adjuvant treatment
- •Primary tumours Developer 5 years previous to the inclusion, except in situ cérvix carcinoma or skin basocellular cancer properly treated
- •Non-controlled hypertension or cardiovascular disease clinically significant (active):
- •Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
- •Heart attack (≤ 6 months prior to inclusion)
- •Instable angina
- •Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
- •Severe cardiac arrhythmia that require medication
- •Significant ophthalmology anomalies
- •Deficit in dihydropyrimidine dehydrogenase (DPD)
- •Unable to take oral drug. Previous surgical process that affect the absorption or make the needed to have intravenous feeding or parenteral nutrition with lipids.
- •Pregnancy women or in latency period. Negative pregnancy test needed 7 days prior to initiation drug study
- •Actual or 30 days previous to study treatment with other investigational drug or participation in other trial
- •Previous treatment with Capecitabine or EGFR inhibitor.
- •Any other disease, metabolic disease
- •Known hypersensibility to any study drug or any of their component, or to 5-fluorouracile
研究组 & 干预措施
Unique arm
Experimental
6 cycles (3 weeks each one) of :
- capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks
- erlotinib (Tarceva®) 150mg/day, oral. Days: every days
干预措施: capecitabine + erlotinib (Drug)
结局指标
主要结局
Objective response rate following RECIST criteria
时间窗: within study period
次要结局
- Overall survival(within study period)
- 6 months survival rate(within first 6 months after study inclusion)
- Progression Free Survival (PFS)(Time from study inclusion to disease progression)
- Time to treatment failure (TTF)(Time from study inclusion to treatment failure)
- To determine the index of clinical benefit(at the end of the study)
- To determine the safety and tolerability of erlotinib and capecitabine when administered together(Within study period)
研究者
研究点 (8)
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