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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00697619
• Date of registration: 11/06/2008
• Primary sponsor: Sun Yat-sen University
• Public title: To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
• Scientific title: 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
• Date of first enrolment: September 2005
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00697619
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Li Zhang, Master
• Affiliation: Cancer Center of Sun Yat-Sen University (CCSU)

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Nasopharyngeal Cancer

Intervention(s)

Drug: Zometa (zoledronic acid)

Primary Outcome(s)

Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . [Time Frame: Baseline, the first, second and third month]

Secondary ID(s)

CZOL446ECN02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis