INDUCTION CHEMOTHERAPY WITH FOLFOXIRI PLUS CETUXIMAB AND MAINTENANCE WITH CETUXIMAB OR BEVACIZUMAB THERAPY IN UNRESECTABLE KRAS WILD-TYPE METASTATIC COLORECTAL CANCER PATIENTS - MACBETH

G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST0 个研究点开始时间: 2012年3月7日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•? Histologically confirmed colorectal adenocarcinoma; ? Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis; ? KRAS 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 and renal 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 containing oxaliplatin is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse; ? Previous adjuvant chemotherapy with fluoropyrimidine monotherapy is allowed if more than 6 months have elapsed between the end of adjuvant and first relapse; ? At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery; ? Written informed consent to experimental treatment and KRAS analysis
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 85
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•? Prior palliative chemotherapy; ? Prior treatment with EGFR or VEGF 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: cerebrovascular accidents or myocardial infarction in the 12 months before treatment start, unstable angina, grade 2 NYHA chronic heart failure, uncontrolled arrhythmia, uncontrolled hypertension; ? Serious, non-healing wound, ulcer, or bone fracture; ? Evidence of bleeding diathesis or coagulopathy; ? Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start; ? Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes or chronic, daily treatment with high-dose aspirin (>325 mg/day); ? Subtotal colectomy, malabsorption syndrome and chronic inflammatory bowel disease (i.e. ulcerative colitis, Chron syndrome); ? Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.

发起方

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