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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00697619
First received: June 11, 2008
Last updated: March 4, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Cancer
Drug: Zometa (zoledronic acid)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . [ Time Frame: Baseline, the first, second and third month ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Other Name: Zometa
No Intervention: Contorl Group
Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697619

Locations
China, Guangdong
Li Zhang
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Novartis
Investigators
Principal Investigator: Li Zhang, Master Cancer Center of Sun Yat-Sen University (CCSU)
  More Information

No publications provided

Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00697619     History of Changes
Other Study ID Numbers: CZOL446ECN02
Study First Received: June 11, 2008
Results First Received: December 19, 2011
Last Updated: March 4, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasm Metastasis
Nasopharyngeal Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014