Last updated on July 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Colorectal Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 mol/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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.