NCT00321100

Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Detailed description

Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	bevacizumab	Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
DRUG	cetuximab	Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle
DRUG	Oxaliplatin	Oxaliplatin 130mg/m2 IV day 1 every 21 days
DRUG	Capecitabine	Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Timeline

• Start date: 2006-04-12
• Primary completion: 2009-04-01
• Completion: 2013-12-18
• First posted: 2006-05-03
• Last updated: 2022-01-12
• Results posted: 2022-01-12

Locations

1 site across 1 country: United States