At a glance
ClinicalIndex Comparison Record- ✓Documented advanced, locally recurrent, or metastatic head and neck carcinoma untreatable by surgical resection or radiation therapy
- ✓Taxane-naïve (no prior docetaxel or paclitaxel)
- ✓Prior chemotherapy for advanced/metastatic disease allowed: 1 regimen only
- ✓Patients who received chemoradiation as primary therapy for advanced head and neck cancer are eligible
- ✕Peripheral neuropathy ≥grade 2
- ✕Congestive heart failure, second or third degree heart block, or myocardial infarction within 12 months
- ✕Severe hypersensitivity reaction to polysorbate 80
- ✕Prior unanticipated severe reaction to fluoropyrimidine therapy or hypersensitivity to 5-fluorouracil
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial Evaluating Weekly Docetaxel and Capecitabine in Patients With Metastatic or Advanced, Locally, Recurrent Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating Docetaxel and Capecitabine for Head and Neck Cancer. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the effectiveness and side effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer. Patients with advanced or recurrent head and neck cancer, which is untreatable by surgery or radiation therapy are eligible for this study. Standard treatment for advanced or recurrent head and neck cancer involves the use of chemotherapy.
Study Details
Timeline
Interventions
Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.
Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.