Phase II randomized study comparing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis. - UCGI28_PANIRINOX

ICANCER0 sites209 target enrollmentNovember 23, 2016

Overview

No summary available.

Registry

who.int

Start Date

November 23, 2016

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ICANCER

•1\. Age between 18 and 75 years
•2\. ECOG PS between 0 and 1
•3\. Histologically confirmed adenocarcinoma of the colon or rectum
•4\. Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent
•5\. K\-Ras (codons 12, 13, 59, 61, 117, 146\), N\-Ras (codons 12, 13, 59, 61\) and B\-Raf (codon 600\) wild\-type tumor status according to plasma analysis of circulating cell free DNA by Intplex technology
•6\. Measurable disease according to RECIST version 1\.1
•7\. Adequate hematologic, hepatic and renal functions:
•Absolute neutrophil count (ANC) \=1\.5 x 109/L
•Haemoglobin \=9 g/dL
•Platelets (PTL) \=100 x 109/L

•1\. History of other malignancy within the previous 5 years (except for appropriately treated in\-situ cervix carcinoma and non\-melanoma skin carcinoma)
•2\. Adjuvant treatment with oxaliplatin
•3\. Previous treatment for metastatic disease
•4\. Patients who received any chemo\- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test
•5\. Brain metastases
•6\. Patients with a history of severe or life\-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study
•7\. Patient with history of pulmonary fibrosis or interstitial pneumonitis
•8\. Previous organ transplantation, HIV or other immunodeficiency syndromes
•9\. Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, symptomatic congestive heart failure, uncontrolled hypertension…)
•10\. Persistent peripheral neuropathy \>grade1 (NCI CT v4\.03\)