Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine (Xeloda®) in Newly Diagnosed Head and Neck Squamous Cell Carcinoma (HNSCC) After Surgery, Radiation and/or Chemotherapy

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: capecitabine
* Procedure: Surgery, chemotherapy and/or radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year. | Drug: capecitabine<br>* Capecitabine 1000mg/day for one year<br>* Other names: Xeloda;Procedure: Surgery, chemotherapy and/or radiotherapy<br>* Surgery, chemotherapy and/or radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance With Treatment . | Compliance is defined as taking at least 80% of the prescribed dose for one year. | within 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free Survival | Time to recurrence or death | Within 3 years of end of study. | 
| Overall Survival | Estimated time from study entry to death from any cause | Within 3 years of end of study | 
| Incidence of Second Primary Tumors |  | Within 3 years of end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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