Clinical trial NCT00629226 (phase 1, status: completed)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: bortezomib, cisplatin
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed squamous cell carcinoma of the head and
             neck, including variants or undifferentiated/poorly differentiated carcinoma

               -  Previously untreated stage IV disease OR residual disease or regionally recurrent
                  disease after prior surgery and/or chemotherapy

          -  Must be eligible to receive full-dose radiotherapy and be evaluated and accepted for
             treatment by a Radiation Oncologist

          -  No clinically measurable distant disease OR has asymptomatic small distant lesions
             outside the radiation field ≤ 3 cm in individual or aggregate diameter for which
             palliation of local and regional disease is clearly warranted

          -  No previously untreated nasopharyngeal cancer (any stage)

               -  Recurrent nasopharyngeal carcinoma allowed

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

          -  ANC ≥ 1,500/mcL

          -  Platelet count ≥ 100,000/mcL

          -  Total bilirubin normal (indirect bilirubin ≤ 3 mg/dL in patients with Gilbert's
             syndrome)

          -  AST and ALT ≤ 2.5 times upper limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Adequate cognitive and neurologic function

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to bortezomib, cetuximab, cisplatin, or other agents used in this
             study

          -  No peripheral sensory neuropathy ≥ grade 2

          -  No concurrent uncontrolled illness including, but not limited to, the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness/social situations that would preclude study compliance

          -  HIV-negative

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

          -  More than 3 months since prior cisplatin

          -  No prior radiotherapy to the head and neck

          -  No prior systemic EGFR inhibitors

          -  No prior bortezomib

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  No concurrent antiretroviral therapy

          -  No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

          -  No concurrent amifostine