To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

A Prospective, Open-label, Randomized Phase III Study to Evaluate the Efficacy of ZOMETA® (Zoledronic Acid) in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.

Inclusion Criteria:

• Age >18, either sex
• Histologically confirmed stage IV nasopharyngeal cancer
• One bone metastasis at least confirmed by imaging
• without chemotherapy or radiotherapy after bone metastasis
• Life expectancy > 6 M
• ECOG <= 2
• Adequate bone marrow reserve (WBC > 3.5 x 109/L, Neutrophile > 1.5 x 109/L, Platelet 100 x 109/L, Hb > 90 g/L)
• Serum creatinine< 2.0 mg/dL (< 1.5 times the upper limit of the normal range for the laboratory of the study center)
• Signed ICF

Exclusion Criteria:

• Women who are pregnant or in lactation
• Patients with hyperostosis
• Systemic treatment for another cancer within the year prior to study entry
• Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
• Initial serum creatinine >265 micromol/L and/or progressive renal disease
• Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
• Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies
• Severe co-morbidity of any type that may interfere with assessment of the patient for the study