Clinical trial NCT01333085 (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, rad001, paclitaxel
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Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
             larynx, or hypopharynx

               -  Locally advanced disease (T4 N0-N3 disease)

               -  Unresectable disease OR resectable disease with surgery contra-indication

               -  No stage I, II, III, or IVc disease

          -  Measurable lesions defined as those accurately measured in ≥ 1 dimension (longest
             diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with
             spiral CT scan

          -  No known brain metastases (cerebral CT scan is not required if no symptom is present)

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Life expectancy > 3 months

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Total bilirubin ≤ 1.25 times upper limit of normal (ULN)

          -  Transaminases ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 5 times ULN

          -  Creatinine clearance ≥ 60 mL/min

          -  Glycemia ≤ 1.5 times ULN

          -  Cholesterol level ≤ 7.30 mmol/L

          -  Serum total protein normal

          -  Oxygen saturation > 88%

          -  Able to swallow pills

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No preexisting neuropathy ≥ grade 2

          -  No uncontrolled disease including any of the following:

               -  Diabetes

               -  Hypertension

               -  Symptomatic congestive heart or pulmonary failure

               -  Renal or hepatic chronic disease

               -  Severe infectious disease

          -  No active hemorrhagic syndrome

          -  No prior history of cancer within the past 5 years, except in situ cervical cancer and
             basal cell skin carcinoma

          -  No psychological, familial, sociological, or geographical condition potentially
             hampering compliance with the study protocol and follow-up schedule

          -  Registration in a national health care system (CMU included)

          -  Not eligible for organ preservation program

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for this cancer

          -  No prior chemotherapy unless received for treatment of another primary tumor
             considered in remission

          -  No prior investigational drug

          -  More than 30 days since prior participation in another therapeutic trial

          -  No prior or concurrent radiotherapy (except anterior radiotherapy) unless received for
             treatment of another primary tumor considered in remission

          -  No concurrent CYP3A4 strong inhibitors (e.g., azole antimycotics [itraconazole,
             ketoconazole], HIV protease inhibitor [ritonavir], erythromycin, anti-epileptic drugs
             [phenytoin, carbamazepine])

          -  No concurrent anti-coagulant therapy