临床试验/NCT01243047

NCT01243047已完成2 期

Intermittent Versus Continuous Erlotinib With Concomitant Modified 'Xelox' (q3W) in First-line Treatment of Metastatic Colorectal Cancer

Chinese University of Hong Kong1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2007年9月最近更新: 2012年11月22日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Chinese University of Hong Kong
入组人数: 60
试验地点: 1
主要终点: To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized phase II study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer.

详细描述

To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
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

•Age ≥ 18 years.
•ECOG performance status of 0-
•Histological proof of adenocarcinoma of colon or rectum with evidence of metastatic disease.
•At least one unidimensionally measurable lesion with a diameter >20 mm using conventional CT or MRI scans, or > 10 mm with spiral CT
•No prior drug treatment or chemotherapy for metastatic disease.
•No prior HER2 or EGFR inhibitors. No prior Oxaliplatin in any clinical setting.
•Absolute granulocyte count > 1.5 x 109/L, platelet count > 100 x 109/L, hemoglobin level > 9.0 g/L, INR < 1.
•Adequate renal & hepatic functions: serum creatinine < 1.5 x upper limit of normal (ULN) or calculated creatinine clearance > 50ml/min, serum bilirubin < 1.5 x ULN, ALT < 2.5 x ULN or < 5 x ULN in case of liver metastases, albumin level > 30g/dL).
•Prior adjuvant or neoadjuvant chemotherapy for non-metastatic CRC is allowed if > 3 months has elapsed since the last dose of chemotherapy.
•Prior open surgery is allowed if > 28 days* has elapsed since the date of surgery, wound healing is satisfactory and recovery from any complications from the surgery is adequate. (*For laparoscopic surgery, > 14 days from the date of surgery).
•No serious medical conditions such as myocardial infarction within 6 months prior to entry, or any other medical conditions that might be aggravated by treatment

排除标准

•Prior history of any malignancies, except basal cell cancer of skin, cervical CIN.
•Treatment with radiotherapy < 30 days.
•Pregnant or lactating females
•Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
•Patients who have not recovered from surgery or other medical illness such as infection.
•Evidence of central nervous system disease. Patients with a history of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from the study
•Patients lacking physical integrity of upper gastrointestinal tract or malabsorption syndrome or unable to swallow tablets.
•Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency).
•Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
•Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
•Known peripheral neuropathy ≥ NCI CTC grade
•Current or recent (within 10 days prior to study treatment start) use of full-dose oral anticoagulant (e.g. warfarin) or thrombolytic agent.

研究组 & 干预措施

Arm B

Active Comparator

Intermittent erlotinib administration (21-day cycle). Erlotinib dose given at 150mg.

干预措施: Chemotherapy (Drug)

Arm A

Active Comparator

Continuous erlotinib administration (21-day cycle). Erlotinib dose given at 100mg daily

干预措施: Chemotherapy (Drug)

结局指标

主要结局

To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate

时间窗: 3 years

次要结局

To evaluate two different schedules of erlotinib and modified XELOX regimen in terms of toxicity, their duration of response and effect on time to progression, progression-free survival and overall survival.(3 years)
To determine the effect of intermittent versus continuous erlotinib administration on pharmacodynamic endpoints using tumor biopsies(3 years)

研究者

发起方

Chinese University of Hong Kong

申办方类型

Other

责任方

Principal Investigator

主要研究者

CCTU

Comprehensive Clinical Trial Unit

Chinese University of Hong Kong

研究点 (1)

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