Clinical trial NCT00410826 (phase 2, status: completed)
Conditions: stage iii squamous cell carcinoma of the hypopharynx, stage iii squamous cell carcinoma of the larynx, stage iii squamous cell carcinoma of the lip and oral cavity, stage iii squamous cell carcinoma of the nasopharynx, stage iii squamous cell carcinoma of the oropharynx, stage iv squamous cell carcinoma of the hypopharynx, stage iv squamous cell carcinoma of the larynx, stage iv squamous cell carcinoma of the lip and oral cavity, stage iv squamous cell carcinoma of the nasopharynx, stage iv squamous cell carcinoma of the oropharynx
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: erlotinib hydrochloride, cisplatin
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Cytological or pathological documented squamous cell carcinoma of oral cavity,
             oropharynx, larynx, and hypopharynx; patients with nasopharyngeal carcinoma can be
             included if the patients have grades I or II tumors according to the World Health
             Organization (WHO) classification

          -  Stage III or IV according to the American Joint Committee on Cancer (AJCC) Cancer
             Staging Manual, Sixth Edition (2002)

          -  Unresectable or resection with significant morbidity

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Measurable Disease, defined according to Response Evaluation Criteria in Solid Tumors
             (RECIST) Criteria

          -  Bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN

          -  Calculated creatinine clearance >= 55ml/min (using the Cockcroft-Gault formula)

          -  Platelet count >= 100 x 10^9 /L

          -  Absolute neutrophil count (ANC) >= 1.25 x 10^9 /L

          -  Signed informed consent

          -  Male and female patients with reproductive potential must use an acceptable
             contraceptive method

          -  Authorization from a dentist to begin radiation therapy

        Exclusion Criteria:

          -  Second primary malignancy that is clinically detectable or clinically significant at
             the time of consideration for study enrollment

          -  Inability or unwillingness to comply with radiotherapy

          -  Evidence of clinically significant congestive heart failure; patients must be able to
             tolerate hydration required during cisplatin chemotherapy

          -  Diarrhea > grade 1 at the time of enrollment

          -  Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell
             carcinoma of head and neck

          -  Prior treatment with an investigational or marketed inhibitor of the EGFR pathway

          -  Use of cytochrome P450 3A4 (CYP3A4) inducers

          -  Presence of systemic metastases (M1)

          -  Pregnant or breast-feeding women

          -  Known human immunodeficiency virus (HIV) infection