capecitabine in treating patients with advanced or recurrent squamous cell carcinoma of the skin

Conditions: Squamous Cell Carcinoma of the Skin; Recurrent Skin Cancer

Summary: phase 2 evaluation of capecitabine in 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.

Eligibility criteria:
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