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NCT00319839 · ClinicalTrials.gov registry record · Phase 2
Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab
A Phase 2 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00319839: Clinical Trial Phase 2 study, sponsored by University of California, Irvine.
NCT00319839 is a Phase 2 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00319839, a Phase 2 study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Primary Objective: To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of Cetuximab on disease progression. Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United States (Jemal et al, 2003), and over 30% of these patients are expected to die of their malignancy. Squamous cell carcinoma accounts for more than 90% of head and neck cancer cases. Although metastatic disease at the time of diagnosis is rather uncommon, and despite aggressive use of up-front concurrent radiation and cisplatin-based chemotherapy, approximately 20% of the patients will develop metastases. Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) have a poor prognosis A subsequent randomized study conducted by ECOG (E1393) compared high-dose paclitaxel (200 mg/m2) as a 24-hour infusion plus cisplatin 75 mg/m2 with G-CSF support, to low dose paclitaxel (135 mg/m2) as a 24-hour infusion, plus cisplatin 75 mg/m2 (Forastiere et al, 2001). Patients with newly diagnosed metastatic or recurrent squamous cell carcinoma of the head and neck, excluding nasopharyngeal primaries were eligible. No prior treatment for recurrent/metastatic disease was allowed, but patients could have received chemotherapy as a part of the initial curative therapy that should have been completed 6 months prior to study. No statistically significant difference could be demonstrated either in response rates or survival between the two arms (Murphy et al, 2001). This study, however, indicated that paclitaxel, a member of the taxane class of anti-tumor agent, is active in head and neck cancer. New agents to treat head and neck cancer need to be investigated. Abraxane, an albumin-bound formulation of paclitaxel has shown significant single-agent activity in breast cancer and in head and neck cancer. Recently, Abraxane has approved for use in metastat
Primary Outcome
To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.
Interventions
- DRUG Cetuximab
- DRUG Abraxane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
Why NCT00319839 stopped before completion
NCT00319839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT00319839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00319839 about?
NCT00319839 is a clinical study titled "Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab". Primary Objective: To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of Cetuximab on disease progression. Approximately 40,000 new cases of head and neck cancer are diagnosed annually in th...
What is the current status of trial NCT00319839?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2006-03. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00319839?
The interventions under investigation include: Cetuximab (DRUG), Abraxane (DRUG).
Who is sponsoring clinical trial NCT00319839?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00319839's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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