Bortezomib and Gemcitabine in Treating Patients With Recurrent or Metastatic Nasopharyngeal Cancer

Inclusion Criteria: Histologically confirmed nasopharyngeal carcinoma (NPC) of one of the following subtypes: Non-keratinizing (WHO type II) Undifferentiated (WHO type III) Disease meets one of the following stage criteria: Stage IVC at diagnosis Persisted, metastasized, or recurred after definitive surgery, radiotherapy, and/or chemotherapy Measurable disease If only measurable disease is within a prior radiation therapy port, disease progression must be clearly demonstrated No known CNS metastases Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin normal SGOT or SGPT ≤ 2.5 times ULN Zubrod performance status 0-2 No peripheral neuropathy > grade 1 No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years Not pregnant or nursing Fertile patients must use effective contraception More than 6 months since prior myocardial infarction No New York Heart Association class III or IV cardiac problems No uncontrolled angina No severe uncontrolled ventricular arrhythmias No acute ischemia by ECG No active conduction system abnormalities No known hypersensitivity to bortezomib, boron, or mannitol See Disease Characteristics No prior therapy with gemcitabine hydrochloride, bortezomib, or other proteasome inhibitors No more than 28 days since discontinuation of single-agent bortezomib Patients with prior gemcitabine hydrochloride treatment are eligible for single-agent bortezomib treatment but NOT for combination treatment No more than one prior chemotherapy regimen for the treatment of metastatic or recurrent NPC At least 28 days since prior treatment and recovered At least 24 weeks since prior adjuvant chemotherapy At least 24 weeks since prior chemotherapy as a radiosensitizer for initial locally advanced disease At least 28 days since prior radiotherapy and recovered At least 28 days since prior surgery and recovered No other concurrent therapy for NPC, including any of the following: Radiotherapy Chemotherapy Immunotherapy Biologic therapy Other investigational drugs Gene therapy No colony-stimulating factor therapy during the first course of study therapy No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients