Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
Public ClinicalTrials.gov record NCT00216138. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00216138
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 19 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2004
- Primary completion
- Aug 31, 2007
- Completion
- Aug 31, 2007
- Last update posted
- May 1, 2011
2004 – 2007
United States locations
- U.S. sites
- 18
- U.S. states
- 7
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Elkhart Clinic | Elkhart | Indiana | 46515 | — |
| Oncology Hematology Associates of SW Indiana | Evansville | Indiana | 47714 | — |
| Fort Wayne Oncology & Hematology, Inc | Fort Wayne | Indiana | 46815 | — |
| Center for Cancer Care at Goshen Health System | Goshen | Indiana | 46527 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | — |
| Quality Cancer Center (MCGOP) | Indianapolis | Indiana | 46202 | — |
| Arnett Cancer Care | Lafayette | Indiana | 47904 | — |
| Medical Consultants, P.C. | Muncie | Indiana | 47303 | — |
| Center for Cancer Care, Inc., P.C. | New Albany | Indiana | 47150 | — |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | — |
| Providence Medical Group | Terre Haute | Indiana | 47802 | — |
| AP&S Clinic | Terre Haute | Indiana | 47804 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Center for Hematology-Oncology of S Michigan | Jackson | Michigan | 49201 | — |
| Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| Methodist Cancer Center | Omaha | Nebraska | 68114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00216138, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2011 · Synced Sep 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00216138 live on ClinicalTrials.gov.