Phase 2 Completed N=60 Randomized Treatment

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

Source: ClinicalTrials.gov NCT00697619 ↗

Enrolled (actual)

Serious AEs

54.2%

Results posted

Mar 2012

Primary outcomePrimary: Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . — 75; 94; 29; 88 nM /mM — p=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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.