gender
Item
1. male or female patients of 18 years of age.
boolean
C0079399 (UMLS CUI [1])
diagnosis; head and neck squamous cell carcinoma
Item
2. patients with a documented diagnosis of recurrent head and neck squamous cell carcinoma patients must have at least one confirmed and evaluable tumor site.* the recurrence must have bidimensional measurements by clinical examination or ct scan. a confirmed recurrence site may also be biopsy-proven
boolean
C0011900 (UMLS CUI [1])
C1168401 (UMLS CUI [2])
recurrent tumor unresectable
Item
3. tumor recurrence which is surgically unresectable (appendix)
boolean
C0521158 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
4. patients must have a karnofsky performance status ≥70% (or the equivalent ecog level of 0-2) (see appendix performance status evaluation) and an expected survival of ≥ three months.
boolean
C0206065 (UMLS CUI [1])
hematologic; reserve cell adequate
Item
5. patients must have adequate hematologic reserve with wbc≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. patients who are on coumadin must have a platelet count of ≥150,000/ mm3
boolean
C0205488 (UMLS CUI [1])
C1514890 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
Blood Chemical Analysis
Item
6. pre-enrollment chemistry parameters must show: bilirubin<1.5x the institutional upper limit of normal (iunl); ast or alt<2.5x iunl and creatinine<1.5x iunl.
boolean
C0005774 (UMLS CUI [1])
Blood coagulation tests
Item
7. pre-enrollment coagulation parameters (pt and ptt) must be ≤1.5x the iunl.
boolean
C0005790 (UMLS CUI [1])
contraception
Item
8. patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. a pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
9. patients must be able to understand and give written informed consent. informed consent must be obtained at the time of patient screening.
boolean
C0021430 (UMLS CUI [1])
Refused Surgery
Item
10. patients who refuse surgery.
boolean
C0749192 (UMLS CUI [1])
pregnant; lactating
Item
1. women who are pregnant or lactating.
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Fertility
Item
2. women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
boolean
C0015895 (UMLS CUI [1])
Intercurrent disease
Item
3. patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
boolean
C0277557 (UMLS CUI [1])
Heart Diseases; respiratory disorders
Item
4. pre-existing cardiac or respiratory disorders
boolean
C0018799 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
malignancy unrelated
Item
5. unrelated malignancy within 3 years
boolean
C0006826 (UMLS CUI [1,1])
C0445356 (UMLS CUI [1,2])
hypersensitivity
Item
6. history of hypersensitivity reactions to other egfr inhibitors
boolean
C0020517 (UMLS CUI [1])
metastatic; disease
Item
7. metastatic disease
boolean
C0036525 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
radiation therapy
Item
8. less than 6 months from prior radiation therapy (arm 1)
boolean
C1522449 (UMLS CUI [1])
cetuximab; exposure
Item
9. previous exposure to cetuximab
boolean
C0995188 (UMLS CUI [1])
C0332157 (UMLS CUI [2])