Head and Neck Cancer
Conditions
Keywords
stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx
Brief summary
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.
Detailed description
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.
Interventions
Capecitabine 1000mg/day for one year
Surgery, chemotherapy and/or radiotherapy
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following primary tumor sites: * Oral cavity * Oropharynx * Nasopharynx * Hypopharynx * Larynx * Unknown primary * Any disease stage allowed * No evidence of active disease * Must have undergone curative surgical resection, radiotherapy, and/or chemotherapy at least 1 month, but no more than 4 years ago PATIENT CHARACTERISTICS: Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * White blood count (WBC) ≥ 3,000/mm\^3 * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Hepatitis B and/or C negative Renal * Creatinine clearance \> 50 mL/min Cardiovascular * No myocardial infarction within the past 12 months * No uncontrolled congestive heart failure * No unstable or uncontrolled angina Gastrointestinal * No lack of physical integrity of the upper gastrointestinal tract * Must be able to swallow tablet * No malabsorption syndrome Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer for which the patient is currently in complete remission * No history of uncontrolled seizures, central nervous system (CNS) disorders, or psychiatric disability that would preclude study compliance or giving informed consent * No ongoing postoperative fistula * No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil * No other serious uncontrolled medical or surgical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics * Prior oral fluoropyrimidine therapy allowed provided it was given in the adjuvant setting and completed ≥ 12 months ago Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * More than 4 weeks since prior major surgery and recovered * No prior organ allografts Other * More than 4 weeks since prior participation in any investigational drug study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Treatment . | within 365 days | Compliance is defined as taking at least 80% of the prescribed dose for one year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free Survival | Within 3 years of end of study. | Time to recurrence or death |
| Overall Survival | Within 3 years of end of study | Estimated time from study entry to death from any cause |
| Incidence of Second Primary Tumors | Within 3 years of end of study | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine Capecitabine 1000mg/day for one year
capecitabine
adjuvant therapy | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Capecitabine |
|---|---|
| Age, Continuous | 58 years |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 35 |
| serious Total, serious adverse events | 2 / 35 |
Outcome results
Compliance With Treatment .
Compliance is defined as taking at least 80% of the prescribed dose for one year.
Time frame: within 365 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine | Compliance With Treatment . | 74 percentage of participants |
Incidence of Second Primary Tumors
Time frame: Within 3 years of end of study
Population: Entire study population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Capecitabine | Incidence of Second Primary Tumors | 3 Participants |
Overall Survival
Estimated time from study entry to death from any cause
Time frame: Within 3 years of end of study
Population: Entire study population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capecitabine | Overall Survival | NA months |
Recurrence-free Survival
Time to recurrence or death
Time frame: Within 3 years of end of study.
Population: All enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capecitabine | Recurrence-free Survival | NA months |