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NCT01437449 · ClinicalTrials.gov registry record · Phase 2
Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
A Phase 2 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT01437449: Completed Phase 2 study, sponsored by Stanford University.
NCT01437449 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437449, a Phase 2 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.
Primary Outcome
Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as fo
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Cisplatin
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-10 |
| Est. Completion | 2019-08 |
| Phase | Phase 2 |
What the finished NCT01437449 record still lists
NCT01437449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01437449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01437449 about?
NCT01437449 is a clinical study titled "Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)". Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cispla...
What is the current status of trial NCT01437449?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2011-10. Estimated completion is 2019-08.
What interventions are being tested in trial NCT01437449?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Cisplatin (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT01437449?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01437449's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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