Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma

Inclusion Criteria:

- Must have histologically or cytologically confirmed squamous cell carcinoma of the
skin. Potential participants who present with "squamous cell carcinoma of unknown
primary lesions" at the time of diagnosis will be eligible if patients have a
plausible primary skin site removed in the past. Similarly, potential participants
with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no
identifiable mucosal primary would also be eligible.

- Must have measurable disease, defined by Response according to Response Evaluation
Criteria in Solid Tumors (RECIST) v1.1 as at least one lesion that can be accurately
measured in at least one dimension of >10 mm by CT, MRI, or calipers

- 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. Patients who are on chronic
daily doses of prednisone of greater than 10 mg are excluded. There is no restriction
on timing of last treatments as long as patients have recovered from all expected
toxicities and at least 21 days have passed since last administration.

- Life expectancy of greater than 3 months

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

- Must have normal organ and marrow function

- Must not be candidates for curative locoregional treatments. Patients with recurrent
locoregional disease following surgery and/or radiation for who a resection is
unacceptably morbid and unlikely to be curative are eligible.

- Women of child-bearing potential and men must agree to use adequate contraception
(barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Have had chemotherapy or radiotherapy within 21 days (6 weeks for nitrosoureas or
mitomycin C) prior to entering the study or those who have not recovered from adverse
events due to agents administered more than 3 weeks earlier

- May not be receiving any other investigational agents

- Known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to either 5-FU/Capecitabine or Interferon

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

- Women who are pregnant or breastfeeding

- Any heart or lung transplant patient on immunosuppressive agents. Renal transplant
patients are allowed if patient is willing to reduce immunosuppressive agents and
understand risk of rejection and possible need to return to dialysis. Patients with
Chronic Lymphocytic Leukemia (CLL) or other hematologic malignancies are allowed as
long as they meet other criteria listed above.