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NCT00851877 · ClinicalTrials.gov registry record · Phase 1
Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT00851877: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT00851877 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00851877, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.
Primary Outcome
Seven participants were assigned nab-paclitaxel in dose of 25mg/m\^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m\^2.
Interventions
- DRUG Cisplatin
- BIOLOGICAL Cetuximab
- DRUG Nab-Paclitaxel
- RADIATION intensity-modulated radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2009-03-01 |
| Est. Completion | 2015-08-03 |
| Phase | Phase 1 |
What the finished NCT00851877 record still lists
NCT00851877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT00851877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00851877 about?
NCT00851877 is a clinical study titled "Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer". RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor grow...
What is the current status of trial NCT00851877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2009-03-01. Estimated completion is 2015-08-03.
What interventions are being tested in trial NCT00851877?
The interventions under investigation include: Cisplatin (DRUG), Cetuximab (BIOLOGICAL), Nab-Paclitaxel (DRUG), intensity-modulated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00851877?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00851877's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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