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

Sponsors and Collaborators:	Sun Yat-sen University Novartis
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00697619

Purpose

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 III

MedlinePlus related topics: Cancer

Drug Information available for: Zoledronic acid Calcium gluconate Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

• 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 ]

Estimated Enrollment:	60
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: No Intervention 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 imageology
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

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

Contacts

Contact: Li Zhang, Master	86-20-8734-3366(O)	zhangli6@mail.sysu.edu.cn
Contact: Su Li, Master	86-20-8734-3145(O)	lisusu@163.net

Locations

China, GuangDong
SunYat-senU	Recruiting
GuangZhou, GuangDong, China
Principal Investigator: Li Zhang, Master

Sponsors and Collaborators

Sun Yat-sen University

Novartis

Investigators

Principal Investigator:

Li Zhang, Master

Cancer Center of Sun Yat-Sen University (CCSU)

More Information

Responsible Party:	Cancer Center of Sun Yat-Sen University ( LZhang )
Study ID Numbers:	CZOL446ECN02
Study First Received:	June 11, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697619
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Zoledronic acid
Ergocalciferols
Pharyngeal Neoplasms
Pharyngeal Diseases
Nasopharyngeal Neoplasms

Calcium, Dietary
Nasopharyngeal carcinoma
Vitamin D
Head and Neck Neoplasms
Neoplasm Metastasis
Stomatognathic Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

Physiological Effects of Drugs
Nasopharyngeal Diseases
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009