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NCT00833261 · ClinicalTrials.gov registry record · Phase 2
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
A Phase 2 study of Head and Neck Cancer, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 4
- Study locations
NCT00833261: Completed Phase 2 study of Head and Neck Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT00833261 is a Phase 2 study of Head and Neck Cancer that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 37 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00833261, a Phase 2 study of Head and Neck Cancer, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 4
- Study locations
Study Summary
RATIONALE: 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. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
Primary Outcome
The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.
Conditions Studied
Interventions
- DRUG cetuximab
- DRUG Nab-Paclitaxel
- DRUG cisplatin
- RADIATION intensity-modulated radiation therapy
Study Locations (4)
Texas
- Baylor Research Institute - Dallas
- University of Texas Southwestern Medical Center - Dallas - Dallas
Ohio
- University Hospitals of Cleveland - Cleveland
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2008-12 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT00833261 record still lists
NCT00833261 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 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which cetuximab is the first listed.
NCT00833261 reports a single indexed study location in Texas, Ohio, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00833261 about?
NCT00833261 is a clinical study titled "Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer". RATIONALE: 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. Drugs used in chemotherapy, such as cisplatin, work in differ...
What is the current status of trial NCT00833261?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2008-12. Estimated completion is 2016-05.
What conditions does trial NCT00833261 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT00833261?
The interventions under investigation include: cetuximab (DRUG), Nab-Paclitaxel (DRUG), cisplatin (DRUG), intensity-modulated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00833261?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00833261 being conducted?
This trial has 4 study locations across Ohio, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00833261's enrollment target sits among peer trials
37 159th of 250 higher than 89 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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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