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NCT00140556 · ClinicalTrials.gov registry record · Early Phase 1

Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer

A Early Phase 1 study of Head and Neck Cancer and Pharynx Cancer, sponsored by David M. Brizel, MD.

Completed
Registry status
Early Phase 1
Development phase
28
Enrollment target
1
Study location

NCT00140556 is a Early Phase 1 study of Head and Neck Cancer and Pharynx Cancer that has completed, run by David M. Brizel, MD. The registered enrollment target is 28 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00140556, a Early Phase 1 study of Head and Neck Cancer and Pharynx Cancer, has completed, sponsored by David M. Brizel, MD.

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

Study Summary

Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly and increases the risk of treatment failure. The addition of EGFR blockade to RT alone increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer. This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will be determined.

Interventions

  • DRUG Bevacizumab
  • DRUG Cisplatin
  • DRUG Erlotinib
  • RADIATION Chemoradiotherapy

Study Locations (1)

North Carolina

  • Department of Radiation Oncology; Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2005-08
Est. Completion 2010-04
Phase Early Phase 1

Sponsor

David M. Brizel, MD

2 total trials

What the Registry Record Tells You About NCT00140556

The ClinicalTrials.gov registry entry for NCT00140556 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The listed sponsor is David M. Brizel, MD, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.

NCT00140556 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00140556 about?

NCT00140556 is a clinical study titled "Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer". Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models r...

What is the current status of trial NCT00140556?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2005-08. Estimated completion is 2010-04.

What conditions does trial NCT00140556 study?

This clinical trial studies the following conditions: Head and Neck Cancer, Pharynx Cancer.

What interventions are being tested in trial NCT00140556?

The interventions under investigation include: Bevacizumab (DRUG), Cisplatin (DRUG), Erlotinib (DRUG), Chemoradiotherapy (RADIATION).

Who is sponsoring clinical trial NCT00140556?

This trial is sponsored by David M. Brizel, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00140556 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

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