Clinical trial NCT00281840 (phase 2, status: completed)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

               -  Stage III or IV disease

                    -  No evidence of distant metastases

               -  No salivary gland or paranasal sinus squamous cell carcinoma

          -  No disease with close proximity to a major vessel

          -  Measurable disease

          -  No known CNS or brain metastases

               -  Patients with intracranial extension without cerebral involvement may be eligible

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy > 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL

          -  Bilirubin normal

          -  AST and ALT ≤ 2 times upper limit of normal

          -  PT normal

          -  Creatinine normal OR

          -  Creatinine clearance ≥ 60 mL/min

          -  Urine protein: creatinine ratio < 1.0

          -  No bleeding diathesis or coagulopathy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biological composition to study drugs

          -  No pre-existing peripheral neuropathy ≥ grade 2

          -  No ongoing or active infection

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No New York Heart Association class II-IV congestive heart failure

          -  No significant arrhythmias requiring medication

          -  No myocardial infarction within the past 6 months

          -  No stroke within the past 6 months

          -  No symptomatic coronary artery disease

          -  No second- or third-degree heart block or bundle branch block

          -  No unstable angina pectoris

          -  No hypertension (i.e., blood pressure ≥ 150/100 mm Hg)

          -  No other clinically significant heart disease

          -  No significant traumatic injury within the past 4 weeks

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No HIV positivity

          -  No other malignancy within the past 5 years except squamous cell or basal cell skin
             cancer or carcinoma in situ of the cervix

          -  No other uncontrolled illness

          -  No poorly compliant patients

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy

          -  No prior investigational anticancer agents

          -  More than 4 weeks since prior major surgery

          -  More than 1 week since prior minor surgery, fine-needle aspiration, or core needle
             biopsy

          -  No concurrent major surgery except planned neck dissection

          -  No concurrent routine colony-stimulating factor therapy

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy