Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma
Condition: Squamous Cell Carcinoma of Skin; Carcinoma, Squamous Cell
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Pegylated Interferon alpha-2b; Capecitabine; 5-FU
Intervention description: Drug administration will occur on an outpatient basis at the infusion center at Moffitt Cancer Center. Dose will be weight-based. Starting treatment doses of 3 mcg/kg will be given subcutaneously (SC) injection in the thigh, abdominal wall, or upper arm every week for a total of 27 weeks as tolerated.; Drug administration will be on an outpatient basis. Capecitabine will be administered at an initial dose of 800 mg/m^2 by mouth twice daily on days 1-14 of a 21 day cycle with days 15-21 off. This cycle will be repeated every 21 days during the study for a maximum of 9 cycles as tolerated. Administration via feeding tube in patients unable to swallow is permitted.; If participants are not able to acquire oral capecitabine, then treating physicians will start participants on infusional 5-FU which can be delivered via standard of care. Participants will need to have a port placed for continuous infusion treatments. 5-FU pumps will be activated in the infusion center at Moffitt Cancer Center with a starting dose of 800 mg/m^2 days 1-4, with pump removal on day 5 at the infusion center. 5-FU pumps will be attached every 21 days (1 cycle) for a maximum of 9 cycles.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Capecitabine; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; cutaneous; skin cancer

Summary:

      The purpose of this study is to find out if the combination of two established anti-cancer
      therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically,
      investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and
      Interferon alpha-2b (injection) can help people with advanced cases of squamous cell
      carcinoma of the skin. For participants that are not approved for oral capecitabine, treating
      physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon alpha-2b
      have been used separately to treat squamous cell carcinoma of the skin and are FDA approved
      in other cancer types.
    

Eligibility criteria:

        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.