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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: Completed Phase 1 study of Paranasal Sinus Neoplasms and Cancer of the Larynx, sponsored by Johnny Kao.

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% 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

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.

Primary Outcome

Number of participants with acute and late toxicity

Interventions

  • DRUG erlotinib + celecoxib

Study Locations (1)

New York

  • Mount Sinai School of Medicine - New York

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2007-02
Est. Completion 2010-11
Phase Phase 1
Johnny Kao

2 total trials

What the finished NCT00970502 record still lists

NCT00970502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

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 a single indexed study location in 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.

Similar trials for Paranasal Sinus Neoplasms

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 NCT00970502's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00970502, the US trial registry maintained by the National Library of Medicine. NCT00970502 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.