This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES: I. To evaluate in a phase II study the efficacy (the radiographic assessment of disease status after 2 cycles of therapy) of a combination of docetaxel and capecitabine in subjects with advanced squamous cell carcinoma of the head and neck who are not candidates for surgery or radiation therapy. II. To evaluate the safety and toxicities of docetaxel and capecitabine in subjects with advanced squamous cell carcinoma of the head and neck. III. To descriptively examine the effects of the combination of docetaxel and capecitabine on the quality of life of subjects with advanced squamous cell carcinoma of the head and neck. OUTLINE: Patients receive docetaxel intravenously (IV) over 1 hour on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then periodically thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Faith Regional Health Services Carson Cancer Center
Norfolk, Nebraska, United States
Omaha Veterans Administration Medical Center
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Overall Response Rate of Complete or Partial Response
The response rates of complete or partial response rate as defined by the Response Evaluation Criteria for Solid Tumors at 15 weeks of a chemotherapy regimen involving docetaxel and capecitabine as front line therapy at 95% confidence interval. Complete Response (CR): the disappearance of all target lesions Partial Response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Time frame: At 15 weeks
Progression-free Survival
The Kaplan-Meier method will be used to estimate time to event distributions for progression-free survival. Progression-free survival will be defined as from the first date of therapy until the first notation of clinical progression, relapse or death from any cause.
Time frame: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 5 years
Survival
The Kaplan-Meier method will be used to estimate time to event distributions for survival. Survival will be defined as from the first date of therapy until the date of death from any cause.
Time frame: First date of therapy until the date of death from any cause, assessed up to 5 years
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Ancillary studies