Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Georges Francois Leclerc
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Man or woman
Age ≥ 18 and ≤ 80 years
Performance status of 0 or 1 according to the ECOG score of WHO
Patient with Metastatic colorectal non-curative and progression on therapy in first -line therapy containing 5-fluorouracil and bevacizumab cancer.
Patient with low or intermediate risk defined by modified Kohne's criteria
Hepatic metastases ≥ 1 cm
Evaluation Review (CT chest, abdomen and pelvis ) made in the previous 4 weeks and showing the presence of a measurable lesion according to RECIST 1.1 criteria.
* Creatinin ≤ 1.5 N and creatinin clearance \> 60 ml / min
* Neutrophils ≥ 1.5 . 109 / L
* Platelets ≥ 100 . 109 / L
* Hemoglobin ≥ 9 g / dL ( even if includable patients were transfused ) .
* Albumin ≥ 30 g / L
* Serological hepatitis B , C and HIV negative
Information given and signed informed consent
Patient affiliated to a social security system
For women of childbearing age , the need for effective contraception.
You may not be if
Related to the disease:
Other cancer within 5 years prior to entry into the trial or concomitant (except carcinoma in situ of the cervix or basal cell carcinoma of the skin ) .
Presence of brain metastasis
Prognosis estimated survival \<3 months
Related to treatment :
Presence of a contraindication to bevacizumab ( major surgery in the previous 28 days , the risk of arterial thrombosis, risk of bleeding , deep vein thrombosis without effective anti- coagulant treatment or unbalanced anticoagulant treatment) Concomitant systemic
Immunotherapy , immunosuppressants, corticosteroids ≥ 1mg/kg or hormone therapy : corticosteroids administered chronically , immunosuppressive therapy, biotherapy administered under the management of inflammatory disease (anti -TNF , anti- IL6 ... )
Hypersensitivity to one of the compounds of treatments
Latex Hypersensitivity ( the cap of the syringe containing anakinra contains dry natural rubber, a derivative of latex), which may cause allergic reactions
Peripheral neuropathy grade ≥ 2
History of autoimmune disease or inflammatory
Related to patient conditions :
Participation during or within 30 days prior to study entry to another clinical trial with an experimental molecule.
Serious disease unbalanced, underlying infection that may prevent the patient from receiving treatment
Intestinal occlusion or sub- occlusion or history of inflammatory bowel disease
Pregnancy (test mandatory inclusion pregnancy) , lactation or lack of effective contraception for men and women of childbearing age
Psychiatric disease compromising understanding of the information or the accomplishment of the study
Patient under guardianship, curatorship or judicial protection
Unable to sign the informed consent or to submit to medical follow-up for geographical, social or psychological reasons.
Clareo Health | Study Evaluating the Influence of LV5FU2 Bevacizumab Plus Anakinra Association on Metastatic Colorectal Cancer
