Pharmacokinetics and metabolic activation of capecitabine when given concomitantly with oxaliplatin and the monoclonal antibody cetuximab - Pharmacokinetics of Capecitabine, Oxalipltin and Cetuximab

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 个研究点开始时间: 2011年9月20日最近更新: 2014年6月2日

适应症

试验速览

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•Signed written informed consent,
•Male or female = 18 years of age,
•Diagnosis of histologically confirmed, K-ras wild-type” adenocarcinoma of the colon or rectum,
•Metastatic colorectal carcinoma,
•Karnofsky performance status of > 80 at study entry,
•Eligible for therapy with Cetuximab plus Oxaliplatin and/or Capecitabine
•Leucocytes = 3.0 x 10e9/L and neutrophils = 1.5 x 10e9/L, platelets = 100 x 10e9/L, and hemoglobin = 8 g/dL,
•Bilirubin = 1.5 x ULN,
•ASAT and ALAT = 2.5 x ULN (= 5 x ULN if liver metastasis are present),
•Serum creatinine = 1.5 x ULN.
•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 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•Brain metastasis (known or suspected)
•Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is > 6 months,
•Stage 3 or 4 heart failure defined according to the NYHA criteria,
•Uncontrolled angina,
•Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol,
•Administration of any investigational agent(s) within 4 weeks prior to entry,
•Previous exposure to EGFR-pathway targeting therapy,
•Known grade 3 or 4 allergic reaction to any of the components of the treatment,
•Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the trial),
•Pregnancy or lactation,
•Inadequate contraception (male or female patients) if of childbearing or procreational potential,
•Known drug abuse/ alcohol abuse,
•Legal incapacity or limited legal capacity,
•Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

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