Clinical trial NCT02268695 (phase 2, status: active, not recruiting)
Conditions: head and neck squamous cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: cisplatin, 5-fluorouracile, docetaxel, cetuximab, granulocyte colony-stimulating factor (g-csf)
SMILES: [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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis squamous cell carcinoma of head and neck: oral
             cavity, oropharynx, hypopharynx, larynx (histological confirmation is mandatory at
             least for initial diagnosis)

          -  Recurrence and/or metastatic disease not suitable for local therapy

          -  At least one measurable lesion (RECIST) by CT or MRI

          -  PS < 2

          -  Age ≥ 18 years and < 71 years

          -  Clearance of creatinine > 60ml/mn (MDRD)

          -  Haematological function as follows: absolute neutrophil count > 1.5 x 109/l, platelet
             > 100 x 109/l, hemoglobin ≥ 9.5 g/dl

          -  Hepatic function as followed: bilirubin ≤ Upper limit of normal (ULN); SGOT/SGPT < 1.5
             ULN; AP < 2.5 ULN

          -  Estimated life expectancy > 12 weeks

          -  Informed Consent Form signed

          -  Affiliation to an health insurance

          -  Negative pregnancy test in women of childbearing potential within 14 days prior to
             treatment initiation (premenopausal or less than 12 months of amenorrhea
             post-menopause, and who have not undergone surgical sterilization). Both men and women
             (of childbearing potential) who are sexually active must use adequate contraception,
             during and for at least 6 months post-treatment.

        Exclusion Criteria:

          -  Patients with nasopharyngeal cancer, paranasal sinus cancer or unknown primary

          -  Prior systemic chemotherapy for the head and neck carcinoma, except if given as part
             of a multimodal treatment for locally advanced disease which was completed more than 6
             months prior to study entry

          -  Surgery (excluding diagnostic biopsy) or radiotherapy within 6 weeks before study
             entry

          -  Contra-indication to receive cisplatin

          -  Known dihydropyrimidine dehydrogenase (DPD) deficiency

          -  Administration of prophylactic phenytoin

          -  Recent or planed yellow fever vaccination

          -  Prior dose of cisplatin > 300 mg/m² (a patient who received prior RT + 3 cycles of
             cisplatin or 3 cycles induction TPF, i.e. total dose of cisplatin ≤ 300 mg/m², for
             locally advanced primary HN cancer can be included)

          -  Prior anti-EGFR treatment received less than 12 months before enrolment in the trial

          -  Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, docetaxel or cetuximab

          -  Documented or symptomatic brain or leptomeningeal metastasis

          -  Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart
             Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy,
             uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial
             infarction in the last 12 months

          -  Malignancies within 5 years prior to randomization, with the exception of adequately
             treated basal or squamous cell skin cancer and carcinoma in situ of the cervix

          -  Active infection (infection requiring IV antibiotics), including active tuberculosis
             and known and declared human immunodeficiency virus (HIV).

          -  Significant disease which, in the judgment of the investigator, would make the patient
             inappropriate for entry into the trial.

          -  Any social, personal, medical and/or psychologic factor(s) that could interfere with
             the observance of the patient to the protocol and/or the follow-up and/or the
             signature of the informed consent.

          -  Pregnant or breast feeding women