NCT01182610

Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Accelerated Community Oncology Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.

Conditions

• Gastroesophageal Adenocarcinoma
• Adenocarcinoma of the Distal Esophagus
• Adenocarcinomas of the Gastroesophageal Junction
• Adenocarcinoma of the Proximal Stomach

Interventions

Type	Name	Description
DRUG	Panitumumab	Panitumumab 9mg/kg on Days 1, 22, and 43
DRUG	Paclitaxel	Paclitaxel 200mg/m2 on Days 1 and 22
DRUG	Carboplatin	Carboplatin AUC=6 on Days 1 and 22
DRUG	5FU	5FU 225mg/m2/day on Days 1-15 and 22-36

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-08-17
• Last updated: 2012-12-03
• Results posted: 2012-11-28

Locations

1 site across 1 country: United States