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

NCT ID: NCT00697619

Last Updated: 2012-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-09-30

Brief 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.

Conditions

Nasopharyngeal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Group

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.

Group Type: EXPERIMENTAL

Zometa (zoledronic acid)

Intervention Type: DRUG

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

Contorl Group

Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Zometa

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Zhang, Master

Role: PRINCIPAL_INVESTIGATOR

Cancer Center of Sun Yat-Sen University (CCSU)

Locations

Li Zhang

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

CZOL446ECN02

Identifier Type: -

Identifier Source: org_study_id