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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nasopharyngeal Cancer

Intervention / Treatment
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* Drug: Zometa (zoledronic acid)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy. | Drug: Zometa (zoledronic acid)<br>* Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily<br>* Other names: Zometa;|
| No Intervention: Contorl Group<br>Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . |  | Baseline, the first, second and third month |