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

Not Recruiting

Trial ID: NCT01823679


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

Official Title

A Phase 2 Study of Capecitabine in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology



   - 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)


   - 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

   - Pregnant

   - Lactating


drug: capecitabine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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