Efficacy of Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UNICANCER
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically proven adenocarcinoma of the colon expressing non-mutated (wild-type) KRAS.
Progressive metastatic disease after first-line treatment with chemotherapy alone: based on 5-FU (iv or per os) with irinotecan or oxaliplatin associated to bevacizumab.
Prior adjuvant chemotherapy (of the primary tumor) with fluoropyrimidine and oxaliplatin is allowed if the time interval between the end of this chemotherapy and the beginning of the first-line metastatic treatment is ≥ 6 months.
Measurable disease (at least one measurable metastatic lesion) according to the RECIST V1.1 criteria (the lesion should not be located in a previous field of radiation).
Previous radiotherapy is authorized if discontinued ≥ 15 days prior to randomization and if the measurable metastatic lesions are outside the radiation area.
Sites of disease evaluated within 28 days prior to randomization with thoracic-abdominal-pelvic CT scan (or abdominal-pelvic MRI plus Chest Xray)
Hepatic transaminases ≤ 2.5 times upper limit of normal (ULN) (≤ 5 ULN in case of hepatic metastases), alkaline phosphatases ≤ 2.5 ULN (≤ 5 ULN in case of hepatic metastases), total bilirubinemia ≤ 1.5 ULN
Renal function (creatinemia ≤1.5 ULN; creatine clearance ≥ 50 mL/mn (Cockcroft and Gault) ; urine test strip \< 2+. If proteinuria is ≥ +2 at inclusion, the serum urea test must be redone and show proteinuria ≤ 1 g/L within 24 h)
Completion of the EORTC QLQ-C30 quality of life form
Negative pregnancy test for women of child-bearing age
Information given to the patient and signed informed consent
Public Health insurance coverage
History of hypertensive crisis or hypertensive encephalopathy
Other concomitant malignancy or history cancer (except carcinoma in situ of the cervix, or non melanoma skin cancer, with curative intent treatment, when considered in complete remission for at least 5 years before randomization.
Any treatment including an experimental drug, or participation in another clinical trial within 28 days preceding inclusion.
Persons deprived of liberty or under guardianship.
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
You may not be if
Known meningeal or brain metastases
Pre-treatment with anti-EGFR
Specific contraindication or known hypersensitivity to one treatment product
Patient with known allergy or hypersensitivity to monoclonal antibodies (bevacizumab, cetuximab
Clinically significant affection of the coronaries or myocardial infarction within 6 months prior to inclusion.
Peripheral neuropathy of grade \> 1 (CTCAE scale version 4.0).
Known depletion of the dihydropyrimidine dehydrogenase (DPD).
Acute intestinal obstruction or sub-obstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colic prosthesis.
