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NCT00970502 · ClinicalTrials.gov registry record · Phase 1
Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
A Phase 1 study of Paranasal Sinus Neoplasms and Cancer of the Larynx, sponsored by Johnny Kao.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00970502 is a Phase 1 study of Paranasal Sinus Neoplasms and Cancer of the Larynx that has completed, run by Johnny Kao. The registered enrollment target is 15 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00970502, a Phase 1 study of Paranasal Sinus Neoplasms and Cancer of the Larynx, has completed, sponsored by Johnny Kao.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal complications. Therefore, less toxic and more effective reirradiation regimens are urgently needed. There are extensive data from animal studies and preliminary human studies showing that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans and appear to have less severe toxicity than conventional chemotherapeutic agents.
Conditions Studied
Interventions
- DRUG erlotinib + celecoxib
Study Locations (1)
New York
- Mount Sinai School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-02 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00970502
The ClinicalTrials.gov registry entry for NCT00970502 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnny Kao, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Paranasal Sinus Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which erlotinib + celecoxib is the first listed.
NCT00970502 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00970502 about?
NCT00970502 is a clinical study titled "Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer". There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradi...
What is the current status of trial NCT00970502?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2007-02. Estimated completion is 2010-11.
What conditions does trial NCT00970502 study?
This clinical trial studies the following conditions: Paranasal Sinus Neoplasms, Cancer of the Larynx, Cancer of the Pharynx, Cancer of the Neck, Cancer of the Head.
What interventions are being tested in trial NCT00970502?
The interventions under investigation include: erlotinib + celecoxib (DRUG).
Who is sponsoring clinical trial NCT00970502?
This trial is sponsored by Johnny Kao, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00970502 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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