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

Primary Purpose

Nasopharyngeal Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zometa (zoledronic acid)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Li Zhang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test Group

Contorl Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 11, 2008
Last Updated
March 4, 2012
Sponsor
Sun Yat-sen University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00697619
Brief Title
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm 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.
Arm Title
Contorl Group
Arm Type
No Intervention
Arm Description
Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Zometa (zoledronic acid)
Other Intervention Name(s)
Zometa
Intervention Description
Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
Primary Outcome Measure Information:
Title
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .
Time Frame
Baseline, the first, second and third month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, Master
Organizational Affiliation
Cancer Center of Sun Yat-Sen University (CCSU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Zhang
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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