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NCT00578071 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cancer of the Esophagus, sponsored by Brian Czito.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target
1
Study location

NCT00578071 is a Phase 1 study of Cancer of the Esophagus that has completed, run by Brian Czito. The registered enrollment target is 29 participants, below the 345-participant average among 3 other Cancer of the Esophagus trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00578071, a Phase 1 study of Cancer of the Esophagus, has completed, sponsored by Brian Czito.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG Capecitabine
  • DRUG Oxaliplatin
  • RADIATION Radiation Therapy (RT)
  • DRUG Panitumumab

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2007-12
Est. Completion 2012-06
Phase Phase 1

Sponsor

Brian Czito

1 total trials

What the Registry Record Tells You About NCT00578071

The ClinicalTrials.gov registry entry for NCT00578071 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 345-participant average among 3 other Cancer of the Esophagus trials with a reported enrollment target (92% lower). The listed sponsor is Brian Czito, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cancer of the Esophagus appearing as the primary indexed condition, and to 4 interventions - of which Capecitabine is the first listed.

NCT00578071 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00578071 about?

NCT00578071 is a clinical study titled "Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer". 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 o...

What is the current status of trial NCT00578071?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-12. Estimated completion is 2012-06.

What conditions does trial NCT00578071 study?

This clinical trial studies the following conditions: Cancer of the Esophagus.

What interventions are being tested in trial NCT00578071?

The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), Radiation Therapy (RT) (RADIATION), Panitumumab (DRUG).

Who is sponsoring clinical trial NCT00578071?

This trial is sponsored by Brian Czito, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00578071 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.