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

You may be eligible if

• 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