Metastatic colorectal carcinoma MedDRA version: 9.1 Level: LLT Classification code 10009973
Conditions
Interventions
Trade Name: VECTIBIX
Pharmaceutical Form: Concentrate for solution for infusion
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: CAMPT
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate;Secondary Objective: - Progression free survival - Secondary R0 surgery on metastases. - Overall survival. - Safety profile;Primary end point(s): The objective of this study is to investigate the response rate in KRAS wild-type and BRAF wil-type mCRC patients receiving FOLFOXIRI + panitumumab as first-line treatment | — |
Countries
Italy
Outcome results
None listed