Clinical trial NCT00498953 (phase 1/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: carboplatin, cisplatin, docetaxel, fluorouracil, lapatinib ditosylate
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, CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed newly diagnosed squamous cell carcinoma of the larynx or
             hypopharynx

               -  T3 or T4 disease of the larynx or T2, T3 or T4 disease of the hypopharynx

               -  Nodal status must be N0, N1, N2a, N2b, N2c or N3

          -  Resectable or unresectable disease (Phase I patients only)

          -  Patient must have tumors amenable to surgery (Phase II patients only)

          -  No distant metastasis

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin < 1.5 times the upper limit of the normal range

          -  Alkaline phosphatase and transaminases < 2.5 times the upper limit of the normal range

          -  Serum creatinine < 1.7 mg/dL

          -  All patients (male and female) must use effective contraception methods if of
             reproductive potential (e.g., implants, injectables, combined oral contraceptives,
             IUDs, sexual abstinence, or vasectomized partner)

          -  Females must not be pregnant or lactating

          -  Patients must have normal cardiac function (LVEF assessed by MUGA or ECHO) and
             clinically satisfactory 12-lead ECG

          -  No serious cardiac illness or medical condition within the past 6 months including,
             but not limited to, any of the following:

               -  History of documented congestive heart failure

               -  High-risk uncontrolled arrhythmias

               -  Angina pectoris requiring antianginal medication

               -  Clinically significant valvular heart disease

               -  Evidence of transmural infarction on ECG

               -  Poorly controlled hypertension (e.g., systolic BP > 180 mm Hg or diastolic BP >
                  100 mm Hg)

          -  Patients should be able to swallow oral agents

          -  No current malignancies at other sites with the exception of cone biopsied carcinoma
             of the cervix and adequately treated basal or squamous cell skin carcinoma or other
             cancer from which the patient has been disease-free for at least five years

          -  Absence of any unstable systemic diseases or active uncontrolled infections

          -  Absence of any psychological, familial, sociological, or geographical condition
             potentially hampering compliance with the study protocol and follow-up schedule

        PRIOR CONCURRENT THERAPY:

          -  No other prior therapy for head and neck cancer

          -  More than 10 days since prior and no concurrent CYP3A4 inducers, including the
             following:

               -  Antibiotics (e.g., all rifamycin class agents [rifampicin, rifabutin, or
                  rifapentine])

               -  Anticonvulsants (e.g., phenytoin, carbamezepine, or barbiturates [phenobarbital])

               -  Oral glucocorticoids (e.g., cortisone [> 50 mg], hydrocortisone [> 40 mg],
                  prednisone [> 10 mg], methylprednisolone [> 8 mg], or dexamethasone [> 1.5 mg])

               -  Antiretrovirals (e.g., efavirenz or nevirapine)

               -  Other (hypericum perforatum [St. John's Wort] or modafinil)

          -  More than 10 days since prior and no concurrent CYP3A4 inhibitors, including the
             following:

               -  Antibiotics (e.g., clarithromycin, erythromycin, or troleandomycin)

               -  Antifungals (e.g., itraconazole, ketoconazole, fluconazole [> 150 mg daily], or
                  voriconazole)

               -  Antiretrovirals and protease inhibitors (e.g., delavirdine, nelfinavir,
                  amprenavir, ritonavir, indinavir, saquinavir, or lopinavir)

               -  Calcium channel blockers (e.g., verapamil or diltiazem)

               -  Antidepressants (e.g., nefazodone or fluvoxamine)

               -  Gastrointestinal agents (e.g., cimetidine or aprepitant)

               -  Other (e.g., grapefruit, grapefruit juice, or camiodarone)

               -  Miscellaneous (e.g., antacids [Mylanta, Maalox, Tums, or Rennies], all herbal
                  [bergamottin or glabridin] or dietary supplements)

          -  Patients may not receive any other anticancer therapy or investigational agents while
             on study