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

Nasopharyngeal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697619
• Other study ID #: CZOL446ECN02
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2008
• Last updated: March 4, 2012
• Start date: September 2005
• Est. completion date: September 2009

Study information

• Verified date: December 2011
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Zometa (zoledronic acid)
Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Locations

Country	Name	City	State
China	Li Zhang	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Novartis

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .		Baseline, the first, second and third month	No