FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation (OPTIPRIME)

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Stop and Go strategy, RAS Wild-type Read More

Inclusion Criteria:

• - Histologically proven colorectal adenocarcinoma without RAS mutation
• Confirmed, non-resectable metastatic disease (Stage IV)
• No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
• At least one measurable metastasis according to the RECIST v1.1 criteria
• Age ≥ 18 years
• WHO ≤ 2
• Neutrophils > 1500 /mm3, platelets> 100 000/mm3, Hb > 9 g/dL
• Creatinine clearance > 50 mL/min according to the MDRD formula
• Serum bilirubin < 25 µmol/L, AST, ALT, Alk Phos < 2.5 x ULN or < 5 x ULN in case of liver metastases
• PT > 60%, albumin ≥ 25g/L
• Estimated life expectancy ≥ 3 months
• Patient affiliated to a social security scheme
• Patient informed and informed consent form signed

Exclusion Criteria:

• - Presence of uncontrolled symptomatic brain metastases
• RAS mutation (KRAS or NRAS mutation)
• Patient taking warfarin. If treated with anticoagulant at the indicated effective dose, this must be replaced with low molecular weight heparin before inclusion
• Known DPD deficiency
• Peripheral neuropathy > 1 (NCI CTCAE v4.0)
• Patient with interstitial pneumonitis or pulmonary fibrosis
• History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment
• Poorly controlled chronic skin disease
• Any known specific contraindication or allergy to the medicinal products used in the study
• Patient simultaneously included in another clinical trial involving an investigational drug (example: chemotherapy, targeted therapy, immunotherapy)
• Arterial hypertension not controlled by medical treatment (Systolic BP ≥ 160 mmHg end/or diastolic BP ≥ 90 mmHg)
• Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
• The following conditions in the 6 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischaemic attack
• Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes
• History of malignant pathologies during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated
• QT/QTc interval > 450 msec for men and > 470 msec for women
• K+ < LNL, Mg2+ < LNL, Ca2+ < LNL
• Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not had a pregnancy test
• Persons in custody or under wardship
• Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons