NCT00469443

Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.

Detailed description

There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
DRUG	5-Fluorouracil	5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
DRUG	Leucovorin	Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
DRUG	Capecitabine	Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
DRUG	Bevacizumab	Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
DRUG	Bevacizumab	Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
DRUG	Irinotecan	Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-05-04
• Last updated: 2010-08-19

Locations

8 sites across 1 country: Greece