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Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer

NCT00578071 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2015-07-02

Study results available
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Summary

The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal junction. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Conditions

  • Cancer of the Esophagus

Interventions

DRUG

Panitumumab

Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.

DRUG

Capecitabine

Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation

DRUG

Oxaliplatin

Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation

RADIATION

Radiation Therapy (RT)

Daily for 6 weeks

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Brian Czito

    lead OTHER

Principal Investigators

  • Brian Czito, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-07-31
Completion
2012-06-30

Countries

  • United States

Study Locations

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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 NCT00578071 on ClinicalTrials.gov