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NCT00736619 · ClinicalTrials.gov registry record · Phase 1
Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 1 study of Head Neck Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 5
- Study locations
NCT00736619 is a Phase 1 study of Head Neck Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 25 participants, below the 37-participant average among 6 other Head Neck Cancer trials with a reported enrollment target (32% lower). The trial reports 5 study locations across 2 states.
The verdict
NCT00736619, a Phase 1 study of Head Neck Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 5
- Study locations
Study Summary
For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®) + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are chemotherapy drugs which are administered by vein. Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells when given alone or in combination with chemotherapy. The purpose of this study is to establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab and radiation therapy. The investigators want to find out what effects, good and/or bad, the albumin-bound paclitaxel has on you and your head and neck cancer.
Conditions Studied
Interventions
- OTHER Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)
Study Locations (5)
New York
- Memorial Sloan Kettering Cancer Center - Commack
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering at Mercy Medical Center - Rockville Centre
- Memoral Sloan Kettering Cancer Center@Phelps - Sleepy Hollow
New Jersey
- Memorial Sloan Kettering Cancer Center - Basking Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-08 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00736619
The ClinicalTrials.gov registry entry for NCT00736619 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 37-participant average among 6 other Head Neck Cancer trials with a reported enrollment target (32% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Head Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®) is the first listed.
NCT00736619 reports 5 study locations spanning 2 distinct geographic areas - top geographies include New York, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00736619 about?
NCT00736619 is a clinical study titled "Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)". For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®) + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are chemotherapy drugs which ...
What is the current status of trial NCT00736619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2008-08. Estimated completion is 2016-08.
What conditions does trial NCT00736619 study?
This clinical trial studies the following conditions: Head Neck Cancer.
What interventions are being tested in trial NCT00736619?
The interventions under investigation include: Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®) (OTHER).
Who is sponsoring clinical trial NCT00736619?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00736619 being conducted?
This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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