Status:
COMPLETED
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Novartis
Conditions:
Nasopharyngeal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 SR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00697619
Start Date
September 1 2005
End Date
September 1 2009
Last Update
March 7 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Li Zhang
Guangzhou, Guangdong, China