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NCT01316757 · ClinicalTrials.gov registry record · Phase 2
Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
A Phase 2 study, sponsored by Fox Chase Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01316757: Completed Phase 2 study, sponsored by Fox Chase Cancer Center.
NCT01316757 is a Phase 2 study that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316757, a Phase 2 study, has completed, sponsored by Fox Chase Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and erlotinib hydrochloride together works in treating patients with metastatic or recurrent squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with cetuximab and erlotinib hydrochloride may kill more tumor cells.
Primary Outcome
Complete plus partial response as determined by RECIST v 1.1
Interventions
- OTHER laboratory biomarker analysis
- DRUG carboplatin
- DRUG paclitaxel
- BIOLOGICAL cetuximab
- DRUG erlotinib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-02-16 |
| Est. Completion | 2017-10-03 |
| Phase | Phase 2 |
What the finished NCT01316757 record still lists
NCT01316757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01316757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01316757 about?
NCT01316757 is a clinical study titled "Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer". This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and erlotinib hydrochloride together works in treating patients with metastatic or recurrent squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways ...
What is the current status of trial NCT01316757?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2011-02-16. Estimated completion is 2017-10-03.
What interventions are being tested in trial NCT01316757?
The interventions under investigation include: laboratory biomarker analysis (OTHER), carboplatin (DRUG), paclitaxel (DRUG), cetuximab (BIOLOGICAL), erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01316757?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316757's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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