A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
- 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
- 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
- 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
- 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