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

Summary

The main objective is to evaluate progression-free survival (PFS) at 4 months.

The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria.

The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.

Conditions

• Colorectal Cancer

Interventions

DRUG

Oxaliplatin

85mg/m² over 120 mn on D1 every 2 weeks up to progression or toxicity

DRUG

Folinic Acid

400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1 (in the same time that oxaliplatin or irinotecan) every 2 weeks up to progression or toxicity

DRUG

5-fluoro-uracil

400mg/m² in bolus on D1, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity

DRUG

Irinotecan

180 mg/m2 over 90 mn IV on D1 every 2 weeks up to progression or toxicity

DRUG

Bevacizumab

5 mg/kg IV over 90 mn on D1 every 2 weeks up to progression or toxicity

DRUG

Cetuximab

500mg/m² on D1 every 2 weeks up to progression or toxicity

Sponsors & Collaborators

• UNICANCER

  lead OTHER

Principal Investigators

• Jaafar BENNOUNA, Dr · Centre René Gauducheau

• Christophe BORG, Pr · CHU Jean Minjoz-BESANCON

• Christian BOREL, Dr · Centre Paul Strauss-STRASBOURG

• Jean-Pierre DELORD, Pr · Institut Claudius Regaud-TOULOUSE

• Christophe BORG, Pr. · Centre Hospitalier du Mittan-MONTBELIARD

• Jean-François SEITZ, Pr · CHU Timone-MARSEILLE

• Thierry CONROY, Pr · Centre Alexis Vautrin-VANDOEUVRE LES NANCY

• Roger FAROUX, Dr · CHD Vendée-LA ROCHE SUR YON

• Eric FRANCOIS, Dr · Centre Antoine Lacassagne, Nice

• Alice GAGNAIRE, Dr · Hôpital Bocage-DIJON

• Antoine ADENIS, Pr · Centre Oscar Lambret-LILLE

• Cédric LECAILLE, Dr · Polyclinique Bordeaux Nord Aquitaine-BORDEAUX

• Gaël DEPLANQUE, Dr · Groupe hospitalier St Joseph-PARIS

• Pascal ARTRU, Dr · Hôpital Privé Jean Mermoz-LYON

• Oana COJOCARASU, Dr · Centre hospitalier du Mans-LE MANS

• Laurent MIGLIANICO, Dr · CHP Saint Grégoire-SAINT GREGOIRE

• Olivier BOUCHE, Pr · Hôpital Robert Debré - CHU Reims

• You-Heng LAM, Dr · Centre Hospitalier de Cholet

• David TOUGERON, Dr · CHU de Poitiers-POITIERS

• Barbara DAUVOIS, Dr · CHR d'Orléans - Hôpital la Source

• Philippe HOUYAU, Dr · Clinique Claude Bernard, Albi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2015-10-31

Completion

2017-12-31

Countries

• France

Study Locations