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

NCT00697619 | Completed Phase 2 Results

• 1 other identifier: CZOL446ECN02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .

  Baseline, the first, second and third month

Study Arms (2)

Test Group

EXPERIMENTAL

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)

Contorl Group

NO INTERVENTION

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

Interventions

Zometa (zoledronic acid) 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

Also known as: Zometa

Test Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Novartis: collaborator

Study Sites (1)

Li Zhang

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Li Zhang
• Organization: Sun Yat-sen University Cancer Centre

zhangli6@mail.sysu.edu.cn

86-20-87343458(O)

Study Officials

• Li Zhang, Master

  Cancer Center of Sun Yat-Sen University (CCSU)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 16, 2008
• Study Start: September 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 7, 2012
• Results First Posted: March 2, 2012

Record last verified: 2011-12

Locations

CN (1)