NCT00393068

Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer. Side effects (toxicity) information will also be collected.

Detailed description

Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery. Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib	Erlotinib
DRUG	Bevacizumab	Bevacizumab
DRUG	Paclitaxel	Paclitaxel
DRUG	Carboplatin	Carboplatin
DRUG	5-FU	5-FU
PROCEDURE	Radiation therapy	Radiation therapy
PROCEDURE	Surgery	Surgery

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-09-01
• Completion: 2011-08-01
• First posted: 2006-10-26
• Last updated: 2022-03-02
• Results posted: 2012-11-30

Locations

9 sites across 1 country: United States