A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer
Public ClinicalTrials.gov record NCT00660218. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00660218
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 53 participants
Conditions and interventions
Conditions
Interventions
- paclitaxel poliglumex Drug
- cetuximab Biological
- radiation therapy (IMRT or 3D-CRT) Radiation
Drug · Biological · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2008
- Primary completion
- Nov 30, 2016
- Completion
- Mar 31, 2017
- Last update posted
- Nov 7, 2021
2008 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00660218, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 7, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00660218 live on ClinicalTrials.gov.