NCT01442649

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

Phase II, Multicentric Randomized Trial, Evaluating the Efficacy of Fluoropyrimidine-based Standard 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-10-01
• Completion: 2017-12-31
• First posted: 2011-09-28
• Last updated: 2022-01-11

Locations

1 site across 1 country: France