RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.
OBJECTIVES: Primary * Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy. Secondary * Determine the time to recurrence, local-regional control, and survival rate in patients treated with this drug. * Determine the incidence of second primary tumors in patients treated with this drug. OUTLINE: This is an open-label study. Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Capecitabine 1000mg/day for one year
Surgery, chemotherapy and/or radiotherapy
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Compliance With Treatment .
Compliance is defined as taking at least 80% of the prescribed dose for one year.
Time frame: within 365 days
Recurrence-free Survival
Time to recurrence or death
Time frame: Within 3 years of end of study.
Overall Survival
Estimated time from study entry to death from any cause
Time frame: Within 3 years of end of study
Incidence of Second Primary Tumors
Time frame: Within 3 years of end of study
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