Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin

Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1
to 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 2 years.

INCLUSION CRITERIA

- Squamous cell carcinoma of the skin or "unknown primary lesions" at the time of
diagnosis if metastatic disease present with a history of plausible primary skin site
removed in the past. Example: squamous cell carcinoma in neck or parotid lymph nodes
with no identifiable mucosal primary but with a history of the removal of one or more
early stage squamous cell carcinomas of the skin in an anatomically relevant lymphatic
drainage region would be eligible

- Measurable disease, defined as at least 1 lesion that can be accurately measured in at
least 1 dimension as ≥ 10 mm with computed tomography (CT) scan; magnetic resonance
imaging (MRI); or calipers during clinical exam

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

- Life expectancy greater than 3 months

- Absolute neutrophil count ≥ 1,000/mcL

- Platelets ≥ 100,000/mcL

- Total bilirubin

- Within normal institutional limits OR

- ≤ 2 x upper limit of normal (ULN) if participant has Gilbert's syndrome (elevated
unconjugated bilirubin from decreased UDP glucuronosyltransferase 1 family,
polypeptide A1 [UGT1A1] activity)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
≤ 2.5 x institutional ULN or up to 5 X ULN if known to be caused by liver metastases

- Creatinine OR

- < 1.3 mg/dL OR

- Creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels
above institutional normal (Note creatinine clearances between 30 and 49 mg/dL
necessitate dose modification)

- For participants with a history of coronary artery disease (CAD)/myocardial infarction
(MI) or congestive heart failure (CHF), ejection fraction (EF) ≥ 50% by multi-gated
acquisition (MUGA) or echocardiogram (exceptions by PI discretion)

EXCLUSION CRITERIA

- Prior treatment with systemic capecitabine or prodrugs

- Prior treatment with systemic fluorouracil (5-FU) or prodrugs (prior topical treatment
with 5FU is permitted if recovered from any toxicities > grade 1, and after at least 5
half-lives of the last systemically administered agent have passed)

- Receiving any other investigational agents or anti-cancer treatments

- Candidates for curative locoregional treatment (patients with recurrent locoregional
disease following surgery and/ or radiation for which a resection is unacceptably
morbid and unlikely to be curative are eligible)

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to capecitabine

- Uncontrolled concurrent illness including, but not limited to:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study
requirements

- Pregnant

- Lactating