Phase 2
N=60
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
Nasopharyngeal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00697619 ↗Enrolled (actual)
60
Serious AEs
54.2%
Results posted
Mar 2012
Primary outcome: Primary: Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . — 75; 94; 29; 88 nM /mM — p=0.370
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zometa (zoledronic acid) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Yat-sen University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . |
75; 94; 29; 88; 17; 52 | 0.370 |
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.
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 3.5 x 109/L, Neutrophile > 1.5 x 109/L, Platelet 100 x 109/L, Hb > 90 g/L)
- 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
Data sourced from ClinicalTrials.gov (NCT00697619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.