PHASE II TRIAL OF FOLFOXIRI PLUS PANITUMUMAB AS FIRST-LINE TREATMENT FOR KRAS AND BRAF WILD-TYPE METASTATIC COLORECTAL CANCER - TRIP

G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST0 个研究点开始时间: 2010年2月26日最近更新: 2013年10月14日

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• Histologically confirmed colorectal adenocarcinoma;  Availability of formalin-fixed paraffin embedded tumor block from primary or metastasis;  KRAS and BRAF wild-type status of primary colorectal cancer or related metastasis;  Unresectable and measurable metastatic disease according to RECIST criteria;  Male or female, aged > 18 years and < 75 years;  ECOG PS < 2 if aged < 71 years;  ECOG PS = 0 if aged 71-75 years;  Life expectancy of more than 3 months;  Adequate haematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL;  Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases < 5 x ULN);  Serum creatinine ≤ 1.5 x ULN;  Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;  At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;  Written informed consent to experimental treatment and pharmacogenomic analyses
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

• Prior palliative chemotherapy;  Prior treatment with EGFR inhibitors;  Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;  Presence or history of CNS metastasis;  Active uncontrolled infections; active disseminated intravascular coagulation;  Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;  Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;  Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception

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G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST