NCT00532909

Phase I Vandetanib Plus Capecitabine, Oxaliplatin and Bevacizumab for Metastatic Colorectal Cancer

A Phase I Trial of Vandetanib Combined With Capecitabine, Oxaliplatin and Bevacizumab for the First-Line Treatment of Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Branimir Sikic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the maximum tolerated dose of Vandetanib with a current standard first-line chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting toxicities associated with the combination.

Conditions

• Anal, Colon, and Rectal Cancers
• Colorectal Neoplasms
• Colon/Rectal Cancer

Interventions

Type	Name	Description
DRUG	Vandetanib	100mg or 300mg By mouth every day continuous
DRUG	Capecitabine	Dosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.
DRUG	Oxaliplatin	dosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.
DRUG	Bevacizumab	Dosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle)

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-09-21
• Last updated: 2012-07-16

Locations

1 site across 1 country: United States