Age
Item
age ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC | Epstein-Barr Virus Negative
Item
histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (scchn). all primary sites are eligible excluding who type iii or ebv nasopharyngeal (who type i and who type ii allowed as long as they are ebv negative)
boolean
C4524839 (UMLS CUI [1])
C0744620 (UMLS CUI [2])
C0014644 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function | Laboratory Procedures Completed | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Acceptable | Serum total bilirubin measurement | Albumin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Glomerular Filtration Rate Cockcroft-Gault formula | Glomerular Filtration Rate 24 Hour urine volume measurement
Item
adequate organ and marrow function as defined below. laboratory tests should be completed within 14 days prior to registration: anc greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, hgb greather than 9g/dl (acceptable to reach this by transfusion), total bilirubin less than or equal to 1.5mg/dl, albumin greater than 2.5 g/dl, ast(sgot)/alt(sgpt) less than or equal to 2.5x institutional upper limit of normal, alkaline phosphatase less than or equal to 2.5 x upper limit of normal, gfr greater than 30 ml/min (by standard cockroft and gault formula or measured via 24 hour urine collection)
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0005841 (UMLS CUI [7,1])
C1879533 (UMLS CUI [7,2])
C1278039 (UMLS CUI [8])
C0201838 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201836 (UMLS CUI [11])
C0201850 (UMLS CUI [12])
C0017654 (UMLS CUI [13,1])
C2924627 (UMLS CUI [13,2])
C0017654 (UMLS CUI [14,1])
C0427843 (UMLS CUI [14,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
women of childbearing potential (wocbp) with negative serum or urine pregnancy test within 7 days of d1 of treatment
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraceptive methods Standard of Care | Contraceptive methods Combination
Item
wocbp and men must agree to use adequate contraception prior to study entry and for duration of treatment under this protocol; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
Malignant Neoplasm incurable
Item
cancer must be considered incurable by the treating clinician
boolean
C0006826 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Exposure to Cisplatin Dose | Exposure to Carboplatin AUC | Exposure to Equivalent Combined
Item
history of prior cumulative exposure to > 300mg/m2 cisplatin, auc of 18 of carboplatin, or their combined equivalent within one year prior to enrollment
boolean
C0332157 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332157 (UMLS CUI [2,1])
C0079083 (UMLS CUI [2,2])
C0376690 (UMLS CUI [2,3])
C0332157 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0205195 (UMLS CUI [3,3])
Operative Surgical Procedures | Therapeutic radiology procedure
Item
surgery or radiation within the four weeks prior to d1 of treatment under this protocol
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Systemic Chemotherapy Previous | Exception Part of Curative treatment
Item
prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry
boolean
C1883256 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1292711 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
Cancer Other Invasive Treatment required for | Requirement Systemic therapy Expected | Exception Squamous cell carcinoma of skin Localized | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasms Requirement Local Ablation Therapy
Item
other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0547070 (UMLS CUI [6,4])
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])