Clinical trial NCT00084318 (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: cisplatin, docetaxel
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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the head and neck meeting the
             following criteria:

               -  Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx
                  (excluding lip, nasopharynx, or sinuses)

               -  Gross total resection must be completed within 7 weeks of randomization, with
                  pathology demonstrating one or more of the following risk factors:

                    -  Histologic extracapsular nodal extension

                    -  Histologic involvement of ≥ 2 regional lymph nodes

                    -  Invasive cancer seen on microscopic evaluation of the resection margin, with
                       no evidence of gross tumor residual.

                    -  Tonsillar cancer patients who undergo transoral excision of all gross tumor
                       are eligible provided extracapsular nodal extension or involvement of ≥ 2
                       regional lymph nodes is histologically confirmed

               -  American Joint Committee on Cancer (AJCC) pathological stage III or IV

          -  No evidence of distant metastases

          -  No synchronous or concurrent head and neck primary tumors

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 2,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin > 8.0 g/dL

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline
             phosphatase meeting 1 of the following parameters:

               -  Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN

               -  Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

               -  Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN

        Renal

          -  Creatinine ≤ 1.5 mg/dL

        Cardiovascular

          -  No unstable angina

          -  No uncontrolled hypertension

          -  No myocardial infarction within the past 6 months (unless successfully treated with
             coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)

          -  No uncontrolled arrhythmia

          -  No congestive heart failure

          -  No more than 2 heart-related hospitalizations within the past year

          -  No other active cardiac disease

        Pulmonary

          -  No more than 2 hospitalizations for chronic obstructive pulmonary disease within the
             past year

        Neurologic

          -  No pre-existing peripheral neuropathy ≥ grade 2

          -  No uncontrolled seizure disorder

          -  No active neurological disease

        Other

          -  No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
             polysorbate 80

          -  No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior anti-epidermal growth factor receptor antibody therapy

        Chemotherapy

          -  More than 3 years since prior cytotoxic chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior head and neck radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  No prior tyrosine kinase inhibitor therapy