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Completed

NCT Number: NCT00697619

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Li Zhang

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Zometa

Primary outcomes

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

    Time frame: Baseline, the first, second and third month

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Novartis

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 16, 2008
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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