Clinical trial NCT00608205 (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: cisplatin, fluorouracil
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 oral cavity, oropharynx,
             larynx, or hypopharynx

               -  No histologic diagnosis other than squamous cell carcinoma

               -  A primary site must be identified

          -  Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease

               -  No evidence of nodal disease below the clavicles or distant hematogenous
                  metastases (M0)

               -  No stage IVC disease (stage IVB disease allowed)

          -  Deemed appropriate for definitive non-operative management with curative intent

               -  Resectable disease is not required

          -  No primary cancer of the nasopharynx, paranasal sinus, or salivary gland

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  WBC > 3,500/mm³

          -  Platelet count > 100,000/mm³

          -  Serum creatinine < 2.0 mg/dL

          -  Alkaline phosphatase < 2 times normal

          -  AST < 2 times normal

          -  Bilirubin ≤ 2.0 mg/dL

          -  Serum calcium normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No unstable or uncontrolled angina

          -  No clinically apparent jaundice

          -  No active infection

          -  No history of any other malignancy (except squamous cell or basal cell skin cancer or
             cervical carcinoma in situ), unless the patient has been continuously disease-free for
             at least 5 years

          -  Not a poor compliance risk

          -  Able to withstand the rigors of intensive treatment

          -  Available for and compliant with adequate long-term follow-up

        PRIOR CONCURRENT THERAPY:

          -  No prior definitive surgery or radiotherapy for this malignancy

          -  No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors
             for any disease Patients who have had previous definitive surgery, or radiation
             therapy for this malignancy, and patients who have had any previous chemotherapy,
             immunotherapy, or EGF receptor inhibition for any disease are ineligible.

        Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or
        salivary gland are ineligible.

        Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active
        infection are ineligible.

        Patients with a history of any other malignancy (except squamous or basal cell skin cancer
        or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously
        disease-free for at least 5 years.

        Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.

        Patients who might be a poor-compliance risk are ineligible.

        Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be
        willing to practice acceptable methods of birth control to prevent pregnancy.