NCT01321957

Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer

FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Martin-Luther-Universität Halle-Wittenberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the efficacy of Irinotecan in combination with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of patients with metastatic colorectal cancer.

Detailed description

5-Fluorouracil and oxaliplatin (FOLFOX-Regimen) in combination with bevacizumab is regarded as standard first-line treatment in metastatic colorectal cancer \[Saltz et al., 2008\]. Current studies established the role of the FOLFOXIRI regimen \[Souglakos et al., 2006, Falcone et al., 2007\]. A further intensification of the therapy seems feasible yielding response rates up to 84% and a disease control rate up to 100% \[Falcone, 2008, Santomaggio, 2009, Masi, 2010\]. This trial evaluates the activity of an intensified first-line therapy for metastatic colorectal cancer compared to standard treatment.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin, 5FU/LV, Bevacizumab	bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
DRUG	5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan	bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)

Timeline

• Start date: 2011-05-01
• Primary completion: 2016-09-01
• Completion: 2018-08-15
• First posted: 2011-03-24
• Last updated: 2018-10-25

Locations

51 sites across 1 country: Germany