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NCT00216138 · ClinicalTrials.gov registry record · Phase 2
Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
A Phase 2 study, sponsored by Hoosier Cancer Research Network.
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00216138 is a Phase 2 study that was terminated before completion, run by Hoosier Cancer Research Network. The registered enrollment target is 19 participants.
The verdict
NCT00216138, a Phase 2 study, was terminated before completion, sponsored by Hoosier Cancer Research Network.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel combination has a synergistic inhibition of tumor growth, resulting in significantly superior efficacy in time to disease progression (TTP), overall survival, median survival and objective tumor response rate compared to docetaxel alone. This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrent/metastatic SCCHN.
Interventions
- DRUG Docetaxel
- DRUG Capecitabine
- DRUG Premedication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2004-03 |
| Est. Completion | 2007-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216138
The ClinicalTrials.gov registry entry for NCT00216138 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoosier Cancer Research Network, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00216138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00216138 about?
NCT00216138 is a clinical study titled "Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck". Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous ...
What is the current status of trial NCT00216138?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2004-03. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00216138?
The interventions under investigation include: Docetaxel (DRUG), Capecitabine (DRUG), Premedication (DRUG).
Who is sponsoring clinical trial NCT00216138?
This trial is sponsored by Hoosier Cancer Research Network, which has 26 total clinical trials registered on ClinicalTrials.gov.
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