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NCT00573989 · ClinicalTrials.gov registry record · Phase 1
Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT00573989: Clinical Trial Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT00573989 is a Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00573989, a Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as pemetrexed and erlotinib, may make tumor cells more sensitive to radiation therapy. Erlotinib and pemetrexed may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving intensity-modulated radiation therapy together with pemetrexed and erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with intensity-modulated radiation therapy and pemetrexed and to see how well they work in treating patients with recurrent or second primary head and neck cancer.
Primary Outcome
Dose at which 100% of participants tolerated the dose
Interventions
- RADIATION intensity-modulated radiation therapy
- PROCEDURE quality-of-life assessment
- DRUG erlotinib hydrochloride
- DRUG pemetrexed disodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2008-03 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
Why NCT00573989 stopped before completion
NCT00573989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which intensity-modulated radiation therapy is the first listed.
NCT00573989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00573989 about?
NCT00573989 is a clinical study titled "Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer". RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as pemetrexed and erlotinib, may make tumor cells more sensitive to radiation therapy. Erlotinib and pemetrexed may also...
What is the current status of trial NCT00573989?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2008-03. Estimated completion is 2017-03.
What interventions are being tested in trial NCT00573989?
The interventions under investigation include: intensity-modulated radiation therapy (RADIATION), quality-of-life assessment (PROCEDURE), erlotinib hydrochloride (DRUG), pemetrexed disodium (DRUG).
Who is sponsoring clinical trial NCT00573989?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00573989's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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