Clinical trial NCT00459043 (phase 2, status: completed)
Conditions: squamous cell carcinoma of head and neck
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: zd6474, docetaxel
SMILES: COC1=C(OCC2CCN(C)CC2)C=C2N=CN=C(NC3=C(F)C=C(Br)C=C3)C2=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically/cytologically documented SCCHN, excluding nasopharyngeal carcinoma.
             Squamous cell carcinomas of unknown primary are allowed. Primary salivary gland tumors
             and tumor of the nasal cavity and paranasal sinuses are not included.

          -  18 years of age or older.

          -  Evaluable or uni-dimensionally measurable local-regional and/or metastatic disease
             that is not amendable to primary surgical resection or radiotherapy.

          -  Life expectancy of at least 3 months.

          -  ECOG performance status of 0-2.

          -  Negative pregnancy test for women of childbearing potential.

          -  Adequate bone marrow function.

        Exclusion Criteria:

          -  Evidence of sever or uncontrolled systemic disease or any concurrent condition which
             in the investigator's opinion makes it undesirable for the patient to participate in
             the trial.

          -  Clinically significant cardiac event such as myocardial infarction, NYHA
             classification of heart disease grade II or higher within 3 months of study entry, or
             presence of cardiac disease that, in the opinion of the investigator, increases the
             risk of ventricular arrhythmia.

          -  History of arrhythmia which is symptomatic or requires treatment or asymptomatic
             sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is
             not excluded.

          -  Previous history of QTc prolongation as a result from other medication that required
             discontinuation of that medication.

          -  Congenital long QT syndrome, or 1st degree relative with unexplained sudden death
             under 40 years of age.

          -  Presence of left bundle branch block.

          -  QTc with Bazett's correction that is unmeasurable or > 480 msec on screening ECG.

          -  Any concomitant medication that may cause QTC prolongation, induce Torsades de Pointes
             or induce CYP3A4 function.

          -  Hypertension not controlled by medical therapy.

          -  Currently active diarrhea that may affect the ability of the patient to absorb
             Zactima.

          -  Pregnant or breast-feeding women.

          -  Previous or concurrent malignancies of other histologies within the last 5 years, with
             the exception of cervical carcinoma in-situ and adequately treated basal cell or
             squamous cell carcinoma of the skin.

          -  Receipt of any investigational agents within 30 days prior to commencing study
             treatment.

          -  Prior treatment with docetaxel.

          -  Last dose of prior chemotherapy discontinued less than 3 weeks before start of study
             therapy.

          -  Last dose of radiation therapy within the last 4 weeks before the start of study
             therapy, except palliative radiotherapy.

          -  Major surgery within 4 weeks, or incompletely healed surgical incision.