Clinical trial NCT01313390 (phase 1/phase 2, status: terminated)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: docetaxel, everolimus
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    lack of recruitment
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the head and neck

               -  Locally advanced or metastatic disease

                    -  No patients with locally advanced disease for whom radiotherapy is indicated

               -  Recurrent disease

               -  Incurable disease

          -  Measurable disease by RECIST criteria

               -  Recurrent disease within a prior radiation field can be considered to be
                  measurable

          -  Patients may have received 1 line of prior chemotherapy (but not a taxane) for locally
             advanced or metastatic disease

          -  Patients may have received prior radiation therapy for locally advanced or metastatic
             disease (but must have completed the radiotherapy > 6 months before recruitment)

               -  No disease relapsed within 6 months of radiotherapy

          -  No evidence of central nervous system metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 10 g/dL

          -  Urea and creatinine normal

          -  Serum bilirubin normal

          -  AST or ALT ≤ 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase < 2.5 times ULN

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 3 months (female) or
             2 months (male) after the last dose of the study treatment

          -  No uncontrolled infection

          -  No mental condition rendering the patient unable to understand the nature, scope, and
             possible consequences of the study

          -  No prior malignancy likely to interfere with the patient's ability to comply with
             treatment and/or follow up

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy for any cancer, except for head and neck cancer

          -  No prior taxane

          -  No prior therapy with any erbB inhibitors (except cetuximab given with radiotherapy,
             as indicated in treatment algorithm)

          -  More than 6 months since prior radiotherapy for locally advanced or metastatic disease

          -  At least 4 weeks since prior investigational drug

          -  No concurrent use of drugs known to inhibit CYP3A4 (except dexamethasone), or block
             P-glycoprotein, including grapefruit juice

          -  No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy,
             radiotherapy, or experimental medications

          -  No concurrent live vaccines during everolimus therapy