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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2008

Last Updated Date

March 4, 2012

Start Date ^ICMJE

September 2005

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00697619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

• 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Nasopharyngeal Cancer

Intervention ^ICMJE

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

Study Arm (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00697619

Other Study ID Numbers ^ICMJE

CZOL446ECN02

Has Data Monitoring Committee

Responsible Party

Li Zhang, Sun Yat-sen University

Study Sponsor ^ICMJE

Sun Yat-sen University

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Principal Investigator:

Li Zhang, Master

Cancer Center of Sun Yat-Sen University (CCSU)

Information Provided By

Sun Yat-sen University

Verification Date

December 2011

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

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