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NCT00049283 · ClinicalTrials.gov registry record · Phase 1
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
A Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Hypopharynx, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00049283: Completed Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Hypopharynx, sponsored by National Cancer Institute (NCI).
NCT00049283 is a Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Hypopharynx that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 154-participant average among 4 other Stage III Squamous Cell Carcinoma of the Oropharynx trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00049283, a Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Hypopharynx, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with docetaxel may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells. Phase I trial to study the maximum tolerated dose (MTD) of combining erlotinib with docetaxel and radiation therapy in treating patients who have locally advanced head and neck cancer
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG docetaxel
- PROCEDURE therapeutic conventional surgery
- RADIATION radiation therapy
- DRUG erlotinib hydrochloride
Study Locations (1)
Ohio
- Case Western Reserve University - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
What the finished NCT00049283 record still lists
NCT00049283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 154-participant average among 4 other Stage III Squamous Cell Carcinoma of the Oropharynx trials with a reported enrollment target (81% lower).
The record links to 10 conditions, with Stage III Squamous Cell Carcinoma of the Oropharynx appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00049283 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00049283 about?
NCT00049283 is a clinical study titled "Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer". Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with...
What is the current status of trial NCT00049283?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2002-09. Estimated completion is 2008-02.
What conditions does trial NCT00049283 study?
This clinical trial studies the following conditions: Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx.
What interventions are being tested in trial NCT00049283?
The interventions under investigation include: laboratory biomarker analysis (OTHER), docetaxel (DRUG), therapeutic conventional surgery (PROCEDURE), radiation therapy (RADIATION), erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00049283?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00049283 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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