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NCT00660218 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer
A Phase 1 study of Carcinoma, Squamous Cell, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT00660218: Completed Phase 1 study of Carcinoma, Squamous Cell, sponsored by State University of New York - Upstate Medical University.
NCT00660218 is a Phase 1 study of Carcinoma, Squamous Cell that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 53 participants, below the 257-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00660218, a Phase 1 study of Carcinoma, Squamous Cell, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
This study involves two phases. Phase I of this study is designed to find out the maximum dose of paclitaxel poliglumex which can be safely given to subjects when combined with cetuximab and radiotherapy in head and neck cancer. Once the maximum safe dose of paclitaxel poliglumex is found, Phase II of the study will continue to find out whether the addition of paclitaxel poliglumex increases tumor response and survival compared to treatment with cetuximab and radiotherapy alone. An additional 20 patients have been added, to balance data. These patients must be HPV negative.
Conditions Studied
Interventions
- BIOLOGICAL cetuximab
- DRUG paclitaxel poliglumex
- RADIATION radiation therapy (IMRT or 3D-CRT)
Study Locations (1)
New York
- SUNY Upstate Medical University - Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2008-03 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
What the finished NCT00660218 record still lists
NCT00660218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 257-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Carcinoma, Squamous Cell appearing as the primary indexed condition, and to 3 interventions - of which cetuximab is the first listed.
NCT00660218 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00660218 about?
NCT00660218 is a clinical study titled "A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer". This study involves two phases. Phase I of this study is designed to find out the maximum dose of paclitaxel poliglumex which can be safely given to subjects when combined with cetuximab and radiotherapy in head and neck cancer. Once the maximum safe dose of paclitaxel poliglumex is found, Phase II ...
What is the current status of trial NCT00660218?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2008-03. Estimated completion is 2017-04.
What conditions does trial NCT00660218 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell.
What interventions are being tested in trial NCT00660218?
The interventions under investigation include: cetuximab (BIOLOGICAL), paclitaxel poliglumex (DRUG), radiation therapy (IMRT or 3D-CRT) (RADIATION).
Who is sponsoring clinical trial NCT00660218?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00660218 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00660218's enrollment target sits among peer trials
53 8th of 14 higher than 7 of 14 other Carcinoma, Squamous Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Squamous Cell 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.
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