Last updated on April 2020

Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers

Are you eligible to participate in this study?

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

  • Conditions: Rectal disorder | Colon Cancer Screening | Rectal Disorders | Colon cancer; rectal cancer | Colorectal Cancer
  • Age: Between 65 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 65 years
  • General condition WHO 2
  • Metastatic rectal or colonic adenocarcinoma, histologically proved on the primary tumour or a metastasis
  • Metastases non-resectable and/or patient inoperable
  • patients where a single agent chemotherapy combined with an anti-angiogenic agent is an appropriate approach
  • At least one measurable target according to RECIST v1.1 criteria, no previously irradiated
  • No previous treatment of the metastatic disease. Previous chemotherapy in an adjuvant situation completed 6 months or more before diagnosis of the metastasis is authorized.
  • Adequate biological examination: Hb > or = 9 g/dl, polynuclear neutrophils > or = 1,500/mm3, platelets > or =100,000/mm3, total bilirubin < or = 1.5 x UNL, creatinine clearance, calculated according to Cockroft-Gault formula, > 50 ml/min creatininemia < 1.5 x UNL, ALP < 5 x UNL, transaminases < 5 x ULN, GGT< 5 x UNL
  • Proteinuria (strip) < 2+; if > or = 2+, test proteinuria over 24 hours which must be 1 g.
  • Central genotyping of thymidylate synthase (TS) in blood DNA
  • Patients treated with anticoagulants (coumadin, warfarin) can be included if the INR can be closely monitored. A change in anticoagulant treatment for low molecular weight heparin is preferable in order to respect indications
  • Signed written informed consent obtained prior to inclusion

Exclusion Criteria:

  • Patients with a primary tumour in place and presenting clinical symptoms (occlusion, haemorrhage)
  • History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
  • Uncontrolled hypercalcemia
  • Uncontrolled hypertension (SBP > 150 mmHg and DBP > 100 mmHg) or history of hypertensive attacks or hypertensive encephalopathy
  • Any progressive pathology not balanced over the past 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency,
  • Any of the following within 6 months prior to inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
  • Any of the following within 3 months prior to inclusion: Grade 3-4 gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event, wound or fractured bone
  • Major surgery during the 28 days preceding the start of treatment
  • Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
  • Treatment with concomitant anticonvulsivant agents that are CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days.
  • Anti-tumoral treatments other than the trial treatments (chemotherapy, targeted therapy, immunotherapy)
  • Macronodular peritoneal carcinosis (risk of perforation)
  • Known DPD deficit
  • Prior history of malignant haemopathy or cancer except those treated more than 5 years ago and considered to be cured, in situ cervical carcinomas and treated skin cancers (excluding melanoma)
  • Patients on new oral anticoagulant therapy (rivaroxaban XARELTOR, apixaban ELIQUIS, dagigatran PRADAXA except if relay by vitamine K antagonist therapy)
  • Any contraindication to the treatments used in the trial
  • Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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