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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: Completed Early Phase 1 study of Head and Neck Cancer and Pharynx Cancer, sponsored by David M. Brizel, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete response (resolution) of tumor on clinical exam.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2005-08 |
| Est. Completion | 2010-04 |
| Phase | Early Phase 1 |
What the finished NCT00140556 record still lists
NCT00140556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00140556's enrollment target sits among peer trials
28 188th of 250 higher than 60 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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