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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Brian Czito

1 total trials

What the finished NCT00578071 record still lists

NCT00578071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 345-participant average among 3 other Cancer of the Esophagus trials with a reported enrollment target (92% lower).

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 a single indexed study location in 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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Source: ClinicalTrials.gov NCT00578071, the US trial registry maintained by the National Library of Medicine. NCT00578071 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.