Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity Hospital, Tours
About this trial
Bevacizumab is a standard drug for metastatic colorectal cancer (mCRC) in combination with cytotoxic chemotherapy. However, inter-individual pharmacokinetic variability was observed for bevacizumab and an exposure-response relationship for efficacy was described for bevacizumab in mCRC patients treated with 1st-line bevacizumab-based chemotherapy.
Eligibility criteria
Qualifiers
Patients aged ≥18 years.
Histologically proven metastatic colorectal adenocarcinoma (on primary tumor and/or metastases) inoperable, 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.
Disqualifiers
Patient with a known non-indication or contraindication to first-line chemotherapy based on bevacizumab.
Cardiovascular contraindication to the prescription of bevacizumab: heart failure, cardiovascular event within 6 months, NYHA ≥ 2 (New York Heart Association), poorly controlled arterial hypertension, history of hypertensive crisis or hypertensive encephalopathy; Grade 3/4 anterior venous thromboembolism (NCI-CTCAE)
Inadequate hematological, hepatic and renal function
Urine test strip for proteinuria ≥ 2+ unless proteinuria < 1 g / 24 hours is demonstrated.
Trial design
Treatments tested in this trial
- Avastin, 25 Mg/mL Intravenous Solution
Treatment groups
244 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Tours
Lead sponsor
CHU DE BESANCON
Collaborator
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator
University Hospital, Clermont-Ferrand
Collaborator
CHU de Reims
Collaborator
CHU de Brest
Collaborator
Pitié-Salpêtrière Hospital
Collaborator
University Hospital, Rouen
Collaborator
Poitiers University Hospital
Collaborator
Institut Paoli-Calmettes
Collaborator
Rennes University Hospital
Collaborator
University Hospital, Toulouse
Collaborator
AP-HP, Hôpital Saint-Louis
Collaborator
HCL Hôpital Edouard Hériot
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
Nantes University Hospital
Collaborator
Centre Hospitalier Universitaire, Amiens
Collaborator
Hôpital Privé Jean Mermoz
Collaborator
AP-HP, Hôpital Henri Mondor
Collaborator
Hopital Paul Brousse
Collaborator
CHG de St-Malo
Collaborator
Polyclinique de Blois
Collaborator
University Hospital, Caen
Collaborator
Central Hospital, Nancy, France
Collaborator
Source ClinicalTrials.gov