NCT00430027

Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection \[and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab\] is feasible and tolerable.

Detailed description

It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.

Conditions

• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	Given 650 mg/m\^2 BID on days of ration therapy, 825 mg/m\^2 day 1-14, day 15-20 off x 4
DRUG	Oxaliplatin	Oxaliplatin 30 mg/m\^2, 130mg/m2 IV Q 21 days x 4
DRUG	Cetuximab	Initial Cetuximab 400 mg/m\^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-02-01
• Last updated: 2013-12-12
• Results posted: 2013-12-12

Locations

1 site across 1 country: United States