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

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

Detailed Description
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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.

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

Conditions
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Squamous Cell Carcinoma of the Skin, Recurrent Skin Cancer

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine 1000 mg/m²<br>Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m² doses on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | Drug: Capecitabine<br>* Given orally<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 9 weeks (3 cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) at 1 Year | Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates. | 1 year | 
| Progression-free Survival (PFS) at 2 Years | Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates. | 2 years | 
| Overall Survival (OS) at 1 Year | Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates. | 1 year | 
| Overall Survival (OS) at 2 Years | Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates. | 2 years |