Biomarker directed treatment in metastatic colorectal cancer - AGMT_ERCC1

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 个研究点目标入组 50 人开始时间: 2011年12月6日最近更新: 2020年9月7日

试验速览

暂无简介。

•Untreated wild-type RAS metastatic colorectal cancer patients
•Previous adjuvant therapy must have been completed = 1 year before therapy initiation.
•Measurable disease with CT or MRI
•ECOG performance status of 0-2
•Adequate tissue to evaluate for genotyping
•Adequate organ function
•Hematologic:
•Absolute neutrophil count > 1,500/µL
•Hemoglobin >9 mg/dl
•Platelet count >100,000 /µl
•Serum creatinine <1.5 x Upper limit of normal (UPN) or estimated clearance > 0 ml/min
•Serum bilirubin < 1.5 mg/dl
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Creatinine clearance of below 30 ml/min
•Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent.
•Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina.
•Other known co-morbidity with the potential to dominate survival
•Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
•Pregnant or breast feeding women
•Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

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