Phase II study with temozolomide and capecitabine for patients with refractory colorectal cancer - TEM

Odense University Hospital0 个研究点目标入组 80 人开始时间: 2013年2月27日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Patients with histologically proven non-resectable adenocarcinoma of the colon or rectum.
•2. Patients who progress and who have been previously treated with fluoropyrimine, irinotecan, oxaliplatin and cetuximab (if K-RAS wild type).
•3. Age = 18 years old.
•4. Performance status (WHO) 0-1.
•5. Adequate bone-, liver and kidney function: hemoglobin > 6,0 µmol/l, neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/l, bilirubin = 1,5 x UNL (Upper Normal Limit), ALAT or ASAT = 5 x UNL, creatinine = 1,5 xUNL, PP % between 0.5 - 1.3, APTT < 1.5 x UNL.
•6. Signed consent form.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•1. Cytotoxic treatment or other experimental treatment within 2 weeks of inclusion.
•8. Other serious disease (ie. heartdisease, AMI within 1 year or ongoing infection).
•9. Patients who cannot follow treatment schedule or evaluation schedule.
•10. Known hypersensitivity towards one of the study drugs.
•11. Any condition or therapy which after the decision of the investigator can put the patient on risk or affect the end-points of the study.
•12. Pregnant women or women who are lactating. Patients who are not using contraception.

发起方