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| Descriptive Information Fields | |||||
| Brief Title † | Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck | ||||
| 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 | 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. |
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| Detailed Description | OUTLINE: This is a multi-center study.
Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy Performance status: ECOG performance status 0 or 1 Life expectancy: At least 3 months Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | - To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | To assess toxicity of the combination [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ] Efficacy and safety analyses on special sub-cohorts [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] To determine the progression free survival and overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ] To assess change in analgesic usage with this protocol therapy [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
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| Condition † | Head and Neck Cancer | ||||
| Intervention † | Drug: Docetaxel Drug: Capecitabine Drug: Premedication |
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| MEDLINE PMIDs | |||||
| Links | Hoosier Oncology Group Home Page ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 19 | ||||
| Start Date † | March 2004 | ||||
| Completion Date | September 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00216138 | ||||
| Organization ID | HOG HN02-40 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Hoosier Oncology Group | ||||
| Collaborators †† | Sanofi-Aventis Hoffmann-La Roche Walther Cancer Institute |
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| Investigators † |
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| Information Provided By | Hoosier Oncology Group | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | April 2, 2008 | ||||