Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin
Condition: Squamous Cell Carcinoma of the Skin; Recurrent Skin Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Skin Neoplasms; Recurrence
Intervention: Capecitabine
Intervention description: Given orally
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell
      carcinoma of the skin.
    

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