NCT00717990

Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment

A Phase II Study of Irinotecan, Capecitabine and Avastin in Patients With Metastatic Colorectal Cancer, Who Have Progressed After 1ST Line Therapy With Folfox/Avastin.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Hospital of Crete · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.

Detailed description

The aim of this phase II study is to evaluate the efficacy of the combination XELIRI/AVASTIN in patients with mCRC, who have progressed in first line treatment with FOLFOX/AVASTIN. For AVASTIN was selected the dosing schedule of the trials TREE 1 and 2 \[17\], where Avastin was combined with capecitabine and oxaliplatin in a three weeks schedule and with adaptation of the dose in the 7,5 mg/kg

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
DRUG	Bevacizumab	Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles
DRUG	Irinotecan	Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-07-18
• Last updated: 2015-10-07

Locations

1 site across 1 country: Greece