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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Nasopharyngeal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .

Outcome Time Frame:

Baseline, the first, second and third month

Safety Issue:

No

Principal Investigator

Li Zhang, Master

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center of Sun Yat-Sen University (CCSU)

Authority:

China: Food and Drug Administration

Study ID:

CZOL446ECN02

NCT ID:

NCT00697619

Start Date:

September 2005

Completion Date:

September 2009

Related Keywords:

  • Nasopharyngeal Cancer
  • Neoplasm Metastasis
  • Nasopharyngeal Neoplasms

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