Chimiothérapie à base de bevacizumab adaptée à la pharmacocinétique du bevacizumab en 1ère ligne de traitement du cancer colorectal métastatique non résécable : étude de phase 3 randomisée multicentrique en double aveugle.

Trial details

Who runs it

Centre Hospitalier Regional Universitaire De Tours

Trial code

EU 2023-507873-16-00

Record updated

2024. augusztus 19.

Original description

The primary objective is to evaluate the effect of doubling the dose of bevacizumab in patients with mCRC treated in 1st line with a bevacizumab-based chemotherapy regimen whose trough serum concentration of bevacizumab is ≤ 15.5 mg /L on day 14 of the first administration of bevacizumab on progression-free survival (PFS).Read full original descriptionShow less

The primary objective is to evaluate the effect of doubling the dose of bevacizumab in patients with mCRC treated in 1st line with a bevacizumab-based chemotherapy regimen whose trough serum concentration of bevacizumab is ≤ 15.5 mg /L on day 14 of the first administration of bevacizumab on progression-free survival (PFS).

Inclusion: Adult patients ≥18 years old; Signature of free, written and informed consent by the patient; Affiliation to a French social security system; Randomization criteria in the experimental phase: - 1st residual serum concentration (Cres) of bevacizumab ≤ 15.5 mg/L measured just before the 2nd infusion of bevacizumab (D14); ECOG Performance status (PS) 0-2; Having a histologically proven metastatic colorectal adenocarcinoma (on primary tumor and/or metastases) that is inoperable and well documented, i.e. not compatible with complete oncological resection at inclusion; For whom treatment with bevacizumab is indicated; For women of childbearing age: effective contraception; No prior treatment with palliative chemotherapy for metastatic disease (in case of adjuvant treatment, interval between the end of chemotherapy and relapse > 6 months); At least one evaluable or measurable lesion assessed by computed tomography (CT) according to RECIST v1.1 criteria; Estimated life expectancy greater than 3 months; Adequate hematological, renal and hepatic biological parameters: . Neutrophils ≥ 1.5x109/L; . Platelets ≥ 100x109/L; . Hemoglobin ≥ 9 g/dL; . Serum creatinine <150 μmol/L; . Bilirubinemia ≤ 1.5 x upper limit of normal (ULN), . Alkaline phosphatase < 5xULN; . Proteinuria < 2+ (urine strip) or ≤ 1 g/24h.

Exclusion: Patient with a known contraindication to first-line chemotherapy based on bevacizumab; In the event of brain metastases, their treatment (surgery and/or radiotherapy) must have been completed more than 4 weeks before the first cycle of chemotherapy under study; Contraindication to bevacizumab (major surgery within 28 days, risk of arterial thrombosis, risk of bleeding, deep vein thrombosis without effective anticoagulant treatment or unbalanced anticoagulant treatment); Serious non-healing wound, active ulcer or untreated bone fracture: ° Other neoplasia (recent or current history), except carcinoma in situ of the cervix treated adequately, localized basal cell or squamous cell carcinoma of the skin managed with curative intent ° Neoplasia in complete remission for more than 5 years; Other illness, which, according to the doctor, is life-threatening to the patient and/or which is uncontrolled; Primary tumor present and symptomatic (occlusion, hemorrhage); Patient under guardianship, curatorship or safeguard of justice; Inadequate hematological, hepatic or renal function; Pregnant or breastfeeding women; Patients unable to give consent.

EU CTIS 2023-507873-16-00