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

Phase 2
18 Years
Open (Enrolling)
Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin

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Trial Information

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


I. To establish the objective response rate, using Response Evaluation Criteria in Solid
Tumors (RECIST) criteria, to capecitabine in patients with metastatic or
unresectable/recurrent squamous cell carcinoma of the skin.


I. To establish the safety profile, progression free and overall survival of capecitabine in
this patient population.


Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14. 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:

- Patients must have squamous cell carcinoma of the skin; patients with "unknown
primary lesions" at the time of diagnosis, if metastatic disease present with a
history of plausible primary skin site removed in the past, are eligible; for
example, patients with 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

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension >= 10 mm with computed tomography (CT)
scan, magnetic resonance imaging (MRI), or calipers by clinical exam

- There is no limitation to prior treatments with local, regional, topical or systemic
agents except for prior systemic treatment with 5- fluorouracil or prodrugs thereof;
prior topical treatment with 5- fluorouracil is permitted; there is no restriction on
timing of last treatments as long as patients have recovered from expected toxicities
of greater than grade 1 and at least 5 half-lives of the last systemically
administered agent have passed

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Life expectancy of greater than 3 months

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 100,000/mcL

- Total bilirubin within normal institutional limits or up to 2 x upper limit of normal
(ULN) if patient 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 upper limit of normal or up to 5 X ULN if known to be caused
by liver metastases

- Creatinine less than 1.3 mg/dL OR creatinine clearance >= 30 mL/min/1.73 m^2 for
patients with creatinine levels above institutional normal; note creatinine
clearances between 30 and 49 mg/dL necessitate dose modification

- Patients must not be candidates for curative locoregional treatments; patients with
recurrent locoregional disease following surgery and/ or radiation for which a
resection is unacceptably morbid and unlikely to be curative are eligible

- Multi gated acquisition scan (MUGA)/echocardiogram must show ejection fraction (EF)
>= 50% for patients with a history of coronary artery disease (CAD)/myocardial
infarction (MI)/congestive heart failure (CHF) or as clinically indicated (principal
investigator [PI] discretion)

Exclusion Criteria:

- Patients who are receiving any other investigational agents or anti-cancer treatments

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

- While not excluded, patients taking Coumadin-derivative anticoagulants (warfarin) or
phenytoin must have international normalized ratio (INR) or drug levels monitored

- Uncontrolled concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant and lactating women are not eligible for this study

- Prior treatment with systemic capecitabine or fluorouracil (5-FU) therapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate assessed using RECIST version 1.1criteria

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

Alexander Colevas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

Related Keywords:

  • Recurrent Skin Cancer
  • Squamous Cell Carcinoma of the Skin
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Squamous Cell
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous



Stanford University Hospitals and Clinics Stanford, California  94305