Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment

Summary

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.

Conditions

• Unresectable Metastatic Colorectal Cancer

Interventions

DRUG

Avastin, 25 Mg/mL Intravenous Solution

Experimental group/ Patients randomized to the experimental group of the trial will receive bevacizumab as an IV infusion at a dose of 10 mg/kg, administered in 2 preparations of 5 mg/kg, every 2 weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity. Control group: Patients randomized to the control group of the trial will receive bevacizumab at a dose of 5 mg/kg and placebo (NaCl) every two weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.

Sponsors & Collaborators

• CHU DE BESANCON

  collaborator UNKNOWN

• Gustave Roussy, Cancer Campus, Grand Paris

  collaborator OTHER

• CHU de Clermont-Ferrand

  collaborator UNKNOWN

• CHU de Reims

  collaborator OTHER

• CHU de Brest

  collaborator UNKNOWN

• AP-HP, Hôpital Pitié- Salpétrière

  collaborator UNKNOWN

• University Hospital, Rouen

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• Institut Paoli-Calmettes

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• AP-HP, Hôpital Saint-Louis

  collaborator UNKNOWN

• HCL Hôpital Edouard Hériot

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  collaborator OTHER

• Hôpital Privé Jean Mermoz

  collaborator UNKNOWN

• AP-HP, Hôpital Henri Mondor

  collaborator UNKNOWN

• AP-HP, Hôpital Paul Brousse

  collaborator UNKNOWN

• CHG de St-Malo

  collaborator UNKNOWN

• Polyclinique de Blois

  collaborator UNKNOWN

• University Hospital, Caen

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• University Hospital, Tours

  lead OTHER

Principal Investigators

• Christophe Borg · Besançon, FRANCE

• Michel Ducreux · Gustave Roussy, FRANCE

• Caroline Petorin · Clermont-Ferrand, FRANCE

• Olivier Bouché · Reims, FRANCE

• Jean-Philippe Metges · Brest, FRANCE

• Jean-Baptiste Bachet · Pitié- Salpétrière, FRANCE

• Frédéric Di Fiore · Rouen, FRANCE

• David Tougeron · Poitiers, FRANCE

• Astrid Lièvre · Rennes, FRANCE

• Rosine Guimbaud · Toulouse , FRANCE

• Thomas Aparicio · St Louis , FRANCE

• Thomas Walter · Edouard Hériot, FRANCE

• Côme Lepage · Dijon, FRANCE

• Yann Touchefeu · Nantes, FRANCE

• Vincent Hautefeuille · Amiens, FRANCE

• Pascal Artru · Jean Mermoz, FRANCE

• Christophe Tournigand · Henri Mondor, France

• Pascal Hammel · Paul Brousse, FRANCE

• Romain Desgrippes · St-Malo, FRANCE

• Philippe Laplaige · Blois, FRANCE

• Karine Bouhier-Leporrier · Caen, FRANCE

• Marie Muller · Nancy, france

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-30

Primary Completion

2028-10-30

Completion

2029-10-30