S0225: Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck

- Locoregionally recurrent or persistent disease

- No thyroid gland, salivary gland, or nasopharynx disease sites

- Must have undergone definitive or post-operative radiotherapy at the time of initial
curative treatment

- Must have undergone salvage surgical resection within the past 56 days

- All current disease must be completely resected, including resection of recurrent
primary disease and/or neck dissection, if regional nodal disease is present

- Surgical margins must be free of disease on final pathological evaluation of
specimens

- No definitive or adjuvant radiotherapy or reirradiation for recurrent or persistent
disease allowed at the time of salvage treatment

- No evidence of distant disease by clinical examination and CT scan of the chest and
upper abdomen (including the liver) within the past 90 days

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Not specified

Renal

- Creatinine clearance ≥ 30 mL/min

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to take oral tablets OR able to take crushed tablets through a gastrostomy tube

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent biologic therapy

- No concurrent filgrastim (G-CSF)

Chemotherapy

- Prior systemic chemotherapy as definitive therapy for head and neck cancer allowed
(prior treatment with fluorouracil allowed, but must be catalogued)

- More than 5 years since prior systemic chemotherapy for any other cancer diagnosis

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent anticancer hormonal therapy

- Concurrent hormonal therapy for non-cancer diagnosis allowed

Radiotherapy

- See Disease Characteristics

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- Recovered from prior surgery