Clinical trial NCT00095875 (phase 3, status: completed)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: carboplatin, cisplatin, docetaxel, fluorouracil
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [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][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        List of Inclusion Criteria:

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

               -  Stage III or IV* disease

               -  One of the following primary tumor sites:

                    -  Oral cavity

                         -  No mandible invasion

                    -  Oropharynx

                    -  Hypopharynx

                    -  Larynx

               -  The following primary tumor sites are excluded:

                    -  Nasal cavity

                    -  Paranasal cavity

                    -  Nasopharynx NOTE: *No evidence of distant metastases by chest x-ray,
                       abdominal ultrasound, or CT scan (for patients with liver function test
                       abnormalities) or bone scan (for patients with local symptoms)

          -  At least 1 uni- or bi-dimensionally measurable lesion

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin > 10 g/dL

        Hepatic

          -  Bilirubin normal

          -  AST or ALT within eligibility range

          -  Alkaline phosphatase within eligibility range

        Renal

          -  Creatinine clearance > 60 mL/min

        Cardiovascular

          -  No unstable cardiac disease despite treatment

          -  No myocardial infarction within the past 6 months

        Pulmonary

          -  No chronic obstructive pulmonary disease, defined as requiring hospitalization for
             pneumonia or respiratory decompensation within the past year

               -  Obstruction caused by the tumor allowed

        Neurologic

          -  No symptomatic peripheral neuropathy > grade 2

          -  No symptomatic altered hearing > grade 2

          -  No history of significant neurologic or psychiatric disorders, including dementia or
             seizures

        Other

          -  No active drug addiction, including alcohol, cocaine, or intravenous drugs within the
             past 6 months

          -  No other malignancy within the past 5 years except adequately treated carcinoma in
             situ of the cervix, basal cell or squamous cell skin cancer, or other cancer
             curatively treated by surgery alone

          -  No active, clinically significant, uncontrolled infection

          -  No autoimmune disease requiring therapy

          -  No unhealed or clinically active peptic ulcer disease

          -  No hypercalcemia

          -  No other serious illness or medical condition

          -  No involuntary weight loss > 25% of body weight within the past 2 months

          -  HIV negative

          -  Not pregnant or nursing

          -  Negative pregnancy test

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy

        Surgery

          -  No prior organ transplantation

          -  No prior surgery for this cancer

               -  Biopsy allowed

        Other

          -  More than 30 days since prior participation in another investigational study

          -  No other concurrent anticancer therapy