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

NCT01182610 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2012-12-03

Study results available
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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

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Accelerated Community Oncology Research Network

    lead OTHER

Principal Investigators

  • Robert Hermann, MD · Accelerated Community Oncology Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01182610 on ClinicalTrials.gov