Study of the effectiveness of a treatment that involves the combination chemotherapy regimen of 5-fluorouracil+Oxaliplatin+irinotecan (Folfoxiri)to a biologic antineoplatic target therapy Erbitux on the end result from treatment with Erbitux or another biologic agent bevacizumab in the patients unresectable that showing the expression of wild-type KRAS oncogene
- Conditions
- RESECTABLE KRAS WILD-TYPE METASTATIC COLORECTAL CANCER PATIENTSMedDRA version: 14.1Level: LLTClassification code 10050035Term: Metastatic colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000840-70-IT
- Lead Sponsor
- G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 10 months-Progression Free Rate (10m-PFR);Secondary Objective: • Response rate, • Resection Rate, • Time to strategy failure, • Time to 2nd PD, • Progression Free Survival (PFS), • Overall Survival (OS), • Safety profile;Primary end point(s): 10 months-Progression Free Rate (10m-PFR);Timepoint(s) of evaluation of this end point: 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -;Timepoint(s) of evaluation of this end point: 18 months