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NCT02124707 · ClinicalTrials.gov registry record · Phase 2
Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02124707 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 14 participants.
The verdict
NCT02124707, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a non-randomized, open-label phase II trial of 38 patients with recurrent or metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating physician at their discretion may continue to treat with weekly cetuximab as maintenance until disease progression. The study is designed to evaluate whether this regimen improves median overall survival (OS) as compared to an historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource intensive. Our study regimen has been used extensively for induction therapy and off-protocol in palliative care, but treatment outcomes have yet to be defined by a clinical trial.
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-06-16 |
| Est. Completion | 2019-10-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02124707
The ClinicalTrials.gov registry entry for NCT02124707 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT02124707 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02124707 about?
NCT02124707 is a clinical study titled "Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN". This is a non-randomized, open-label phase II trial of 38 patients with recurrent or metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuxima...
What is the current status of trial NCT02124707?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2014-06-16. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT02124707?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT02124707?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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