Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma

Inclusion Criteria:

• Biopsy proven nasopharyngeal carcinoma - WHO type 3 (recurrence or metastases)
• metastatic disease or locally recurrent disease not amendable curative therapy
• Patients must have measurable disease
• least one (not more than a total of three prior lines of chemotherapy for metastatic or recurrent disease). This must include at least 1 prior line of platinum-containing chemotherapy.
• An ECOG performance status of 0-2
• Absolute neutrophil count (ANC) ≥1500/mm3
• Hemoglobin 8g/dl (blood transfusion is allowed to correct hemoglobin level).
• PLT ≥ 75,000/mm 3
• Total bilirubin ≤ 2 x upper normal limit (UNL)
• Serum ALT ≤ 5 x UNL
• Serum creatinine ≤ 2 mg/dL
• Serum albumin ≥ 2.5 g/dL
• No known history of brain or leptomeningeal metastasis.
• ≥ 18 years of age.
• Estimated life expectancy ≥ 24 weeks.
• For sexually active women of childbearing potential, negative pregnancy test within 21 days of enrolling on trial.
• must be able to give informed written consent

Exclusion Criteria:

• Patients who have not had at least 1 or more than 3 previous lines of treatment for metastatic or recurrent NPC
• Prior BORTEZOMIB therapy
• Immunotherapy ≤ 4 weeks have elapsed prior to study entry
• Biologic therapy ≤ 4 weeks have elapsed prior to study entry
• Radiation therapy ≤ 4 weeks have elapsed prior to study entry
• Major surgery, or significant traumatic injury ≤3 weeks prior to study entry
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
• Evidence of CNS involvement
• Presence of > grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology.
• Patients with significant local symptoms from metastases which is amenable to radiotherapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to BORTEZOMIB.
• History of other malignancy ≤ 3 years prior to study entry, except for adequately treated basal cell, squamous cell skin cancer or cervical intraepithelial neoplasia.
• Uncontrolled intercurrent illness
• Patients who are pregnant or breast feeding (Sexually active men and women of childbearing potential must use contraception during course of therapy and within 3 months of completion of trial) Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
• Known history of HIV