NCT01532804

2nd-line Treatment of Metastatic Colorectal Cancer

A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

Detailed description

Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors: * Center * Number of metastatic sites: 1 versus \> 1 * Bevacizumab-based first-line therapy: Yes versus No

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab, oxaliplatin and 5FU combination	Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively. Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)
DRUG	Bevacizumab, oxaliplatin and raltitrexed combination	Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively. Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min

Timeline

• Start date: 2011-07-28
• Primary completion: 2016-05-12
• Completion: 2019-01-01
• First posted: 2012-02-15
• Last updated: 2019-12-26

Locations

1 site across 1 country: France