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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Cancer

Treatments: Drug: Zometa (zoledronic acid)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00697619

CZOL446ECN02

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Test Group

Experimental group

Description:

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.

Treatment:

Drug: Zometa (zoledronic acid)

Contorl Group

No Intervention group

Description:

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