Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 11, 2008
March 4, 2012
September 2005
January 2009   (final data collection date for primary outcome measure)
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 ]
Comparing the change of the level of uNTx in the two arms . SMR: Skeletal Morbidity Rate (The number of occurrences of SRE /person /period will be calculated) [ Time Frame: Jan 2009 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00697619 on ClinicalTrials.gov Archive Site
Not Provided
• Proportion of patients experiencing any SRE • Time to first occurrence of any SRE • The change of pain score by VAS [ Time Frame: Jan 2009 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasopharyngeal Cancer
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
  • 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.
    Intervention: Drug: Zometa (zoledronic acid)
  • No Intervention: Contorl Group
    Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00697619
CZOL446ECN02
No
Li Zhang, Sun Yat-sen University
Sun Yat-sen University
Novartis
Principal Investigator: Li Zhang, Master Cancer Center of Sun Yat-Sen University (CCSU)
Sun Yat-sen University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP