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NCT00113347 · ClinicalTrials.gov registry record · Phase 1
Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00113347: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00113347 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113347, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.
Primary Outcome
MTD defined as highest dose level in which 6 patients have been treated with less than or equal to 2 instances of Dose-limiting toxicity (DLT) from 2 sources: 1) Out-of-field toxicity from unirradiated sites secondary to systemic therapy(erlotinib and docetaxel); 2) In-field toxicity from irradiated sites secondary to combined treatment.
Interventions
- DRUG Docetaxel
- RADIATION Radiation Therapy
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-04 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT00113347 record still lists
NCT00113347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00113347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00113347 about?
NCT00113347 is a clinical study titled "Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)". The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.
What is the current status of trial NCT00113347?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2005-04. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00113347?
The interventions under investigation include: Docetaxel (DRUG), Radiation Therapy (RADIATION), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00113347?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00113347's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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