Squamous cell carcinoma of skin | Squamous cell carcinoma of unknown primary origin | Squamous cell carcinoma of skin of neck | Parotid Gland Squamous Cell Carcinoma | Squamous cell carcinoma Facial lymph nodes
Item
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.
boolean
C0553723 (UMLS CUI [1])
C0280097 (UMLS CUI [2])
C1827711 (UMLS CUI [3])
C1335367 (UMLS CUI [4])
C0007137 (UMLS CUI [5,1])
C0229719 (UMLS CUI [5,2])
Measurable Disease Quantity | Measurable lesion Dimension Quantity CT | Measurable lesion Dimension Quantity MRI | Measurable lesion Dimension Quantity Caliper
Item
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
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
C1513041 (UMLS CUI [4,1])
C0439534 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0175720 (UMLS CUI [4,4])
Pharmaceutical Preparations Local | Pharmaceutical Preparations Regional | Pharmaceutical Preparations Topical | Pharmaceutical Preparations Systemic | Exception Systemic therapy Fluorouracil | Fluorouracil Topical Product allowed | Exclusion Prednisone chronic U/day
Item
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 5 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 4 weeks have passed since last administration.
boolean
C0013227 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
|C0013227 (UMLS CUI [2,3])
C1710439 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
C0016360 (UMLS CUI [4,3])
C3215191 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C2828389 (UMLS CUI [6,1])
C0032952 (UMLS CUI [6,2])
C0205191 (UMLS CUI [6,3])
C0456683 (UMLS CUI [6,4])
Life Expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status <=2 (karnofsky >=60%
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function | Bone Marrow function
Item
must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Patients Inappropriate Curative treatment Locoregional | Recurrent disease Locoregional | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure | Excision Unacceptable
Item
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.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C1947913 (UMLS CUI [1,4])
C0277556 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C0728940 (UMLS CUI [5,1])
C1883420 (UMLS CUI [5,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraception, Barrier | Sexual Abstinence
Item
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.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0004764 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse drug events Recovery Lacking
Item
have had chemotherapy or radiotherapy within 4 weeks (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 4 weeks earlier
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0041755 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Investigational New Drugs
Item
may not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound Similar Capecitabine | Allergic Reaction Compound Similar Interferon
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to either capecitabine or interferon
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
C0671970 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C3652465 (UMLS CUI [2,4])
Illness Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
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
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])