Informed Consent
Item
signed, voluntary informed consent provided
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with visits, treatment plan, pharmacokinetics, tests, other procedures
boolean
C0525058 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck | Nasopharyngeal carcinoma | Carcinoma of skin of head/neck | Maxillary Sinus Carcinoma | Head and Neck Carcinoma of unknown primary
Item
confirmed scchn. other primary sites of head and neck carcinoma: nasopharynx, skin, maxillary sinus or unknown primary, are allowed
boolean
C1168401 (UMLS CUI [1])
C2931822 (UMLS CUI [2])
C0559015 (UMLS CUI [3])
C0740487 (UMLS CUI [4])
C3887461 (UMLS CUI [5,1])
C0220647 (UMLS CUI [5,2])
Gastrojejunostomy tube functioning
Item
must have functioning gastrojejunostomy tube
boolean
C3880870 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
Chemoradiotherapy Advanced disease Locally | Therapeutic radiology procedure Advanced disease Locally | Operative Surgical Procedure Advanced disease Locally
Item
may be receiving concurrent chemoradiation, radiation alone or recently completed surgery for locally advanced disease
boolean
C0436307 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
Targeted Therapy Epidermal Growth Factor Receptor
Item
prior treatment with agents targeted to epidermal growth factor receptor not allowed.
boolean
C2985566 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
Toxicity Due to Therapeutic procedure | LABORATORY ABNORMALITIES | Recovery CTCAE Grades | Deglutition Disorder chronic Stable | Xerostomia Stable
Item
any treatment-related toxicity, including laboratory abnormalities, must have recovered to ctcae grade 2 (v.4.0) or baseline, except toxicity not considered safety risk. chronic dysphagia, xerostomia or other local effect from prior surgery or radiation will not be considered exclusion criterion if stable for ≥ 3 months.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1853129 (UMLS CUI [2])
C2004454 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0011168 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0043352 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Gender | Absolute neutrophil count | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | 12 lead ECG Normal | QTc interval | Torsades de Pointes Absent | QTc interval Abnormal Absent
Item
must have adequate organ function determined by: serum creatinine ≤ 1.5 uln (upper limit of normal) or calculated creatinine clearance of ≥ 50 ml/min using the formula: creatinine clearance = [(140-age) x wt (kg) x constant] / creatinine (µmol/l) [constant = 1.23 for men; 1.04 for women]. absolute neutrophil count (anc) ≥ 1.5 x 109/l; leukocytes ≥ 3.0 x 109/l; hemoglobin ≥ 80 g/l (or > 8 g/dl); platelets ≥ 100 x 109/l. total bilirubin ≤ uln; ast (sgot) and alt (sgpt) ≤ 2.5 x uln. 12-lead electrocardiogram (ecg) with normal tracing, or clinically non-significant with no medical intervention; qtc interval ≤ 470 msec, without history of torsades de pointes or other qtc abnormality
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0023508 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201836 (UMLS CUI [11])
C0430456 (UMLS CUI [12,1])
C0205307 (UMLS CUI [12,2])
C0489625 (UMLS CUI [13])
C0040479 (UMLS CUI [14,1])
C0332197 (UMLS CUI [14,2])
C0489625 (UMLS CUI [15,1])
C0205161 (UMLS CUI [15,2])
C0332197 (UMLS CUI [15,3])
Study Subject Participation Status | Clinical Trial
Item
cannot be enrolled on another clinical trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pharmacotherapy Investigational
Item
prior investigational drug therapy within 30 days or 5 half-lives preceding first dose of study drug (whichever longer)
boolean
C0013216 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Pharmaceutical Preparations Dependence CYP2D6 | Metabolic aspects
Item
requirement for drugs highly dependent on cyp2d6 for metabolism since pf-00299804 is a potent cyp2d6 inhibitor
boolean
C0013227 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0057223 (UMLS CUI [1,3])
C0025520 (UMLS CUI [2])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
patients currently taking drugs with risk of torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | Medical condition Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | LABORATORY ABNORMALITIES Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | LABORATORY ABNORMALITIES Interfere with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | LABORATORY ABNORMALITIES Study Subject Participation Status Inappropriate | Lung Diseases, Interstitial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Cerebrovascular accident | Deep Vein Thrombosis | Bacterial Infections | Mycoses | Virus Diseases | Hepatitis B | Hepatitis C | HIV Infection | Absence Symptoms Communicable Disease | Blood Coagulation Disorders | Pharmaceutical Preparations Causing Blood coagulation Unacceptable | Congenital Bleeding Disorder | Blood Coagulation Disorder Acquired
Item
any acute/chronic medical, psychiatric condition or laboratory abnormality that could increase risk of participation, trial drug administration or interfere with interpretation of trial results and, investigator feels, would make patient inappropriate for entry. including: history of interstitial lung disease; uncontrolled hypertension, unstable angina, myocardial infarction, symptomatic congestive heart failure within past year, uncontrolled cardiac arrhythmia, diagnosed/suspected congenital long qt syndrome; history of stroke, deep vein thrombosis, or stable for 6 months without requiring antiarrhythmics/significant change in medical management; active bacterial, fungal or viral infection including hepatitis b/c, and human immunodeficiency virus. testing not required at baseline with no symptoms of infection. history of significant bleeding disorder, or concurrent medications that investigator feels may lead to unacceptable coagulation during perioperative interval, including: congenital bleeding disorders; acquired bleeding disorder within a year
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1853129 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C1853129 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0459471 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C3840291 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0459471 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
C1853129 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0459471 (UMLS CUI [9,3])
C0683954 (UMLS CUI [9,4])
C3843040 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1548788 (UMLS CUI [10,3])
C3840291 (UMLS CUI [11,1])
C2348568 (UMLS CUI [11,2])
C1548788 (UMLS CUI [11,3])
C1853129 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
C0206062 (UMLS CUI [13])
C1868885 (UMLS CUI [14])
C0002965 (UMLS CUI [15])
C0027051 (UMLS CUI [16])
C0742758 (UMLS CUI [17])
C0003811 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
C1141890 (UMLS CUI [19])
C1141890 (UMLS CUI [20,1])
C0750491 (UMLS CUI [20,2])
C0038454 (UMLS CUI [21])
C0149871 (UMLS CUI [22])
C0004623 (UMLS CUI [23])
C0026946 (UMLS CUI [24])
C0042769 (UMLS CUI [25])
C0019163 (UMLS CUI [26])
C0019196 (UMLS CUI [27])
C0019693 (UMLS CUI [28])
C0332197 (UMLS CUI [29,1])
C1457887 (UMLS CUI [29,2])
C0009450 (UMLS CUI [29,3])
C0005779 (UMLS CUI [30])
C0013227 (UMLS CUI [31,1])
C0678227 (UMLS CUI [31,2])
C0005778 (UMLS CUI [31,3])
C1883420 (UMLS CUI [31,4])
C3641106 (UMLS CUI [32])
C0005779 (UMLS CUI [33,1])
C0439661 (UMLS CUI [33,2])
Disease Serious Uncontrolled | Communicable Disease Impairing Investigational Therapy
Item
other serious uncontrolled medical disorder or active infection that would impair ability to receive study treatment as determined by investigator
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
Dementia Limiting Informed Consent | Abnormal mental state Limiting Informed Consent | Dementia Limiting Protocol Compliance | Abnormal mental state Limiting Protocol Compliance
Item
dementia or altered mental status that would limit ability to obtain informed consent and compliance with requirements of the protocol
boolean
C0497327 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0278061 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0497327 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0278061 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Breast Feeding | Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Childbearing Potential Partner Contraceptive methods
Item
patients breastfeeding or pregnant are excluded. those with reproductive potential must have negative pregnancy test within 72 hours of treatment. patients of reproductive potential include any female who has experienced menarche and who has not undergone successful surgical sterilization, or is not postmenopausal. patients of reproductive potential/partners must agree to effective contraception while receiving trial treatment and for at least 3 months after. effective contraception will be judgment of principal investigator or designate
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0700589 (UMLS CUI [5,3])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
inability/lack of willingness to comply with visits, treatment plans, assessments or tests
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])