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

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Outcomes in Nasopharyngeal Carcinoma Serial Plasma EBV DNA for Nasopharyngeal Carcinoma Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma A Trial On 4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation In N2-3 Nasopharyngeal Carcinoma Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients Endostar for Locally Recurrent Nasopharyngeal Carcinoma Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma Intestinal Flora Sequencing for Nasopharyngeal Carcinoma Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s) Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma The Value of Single-cycle TPF Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma The 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Metastatic Nasopharyngeal Carcinoma The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma LMP1- and LMP2-Specific CTLs to Patients With EBV-Positive NPC (NATELLA) Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Administration of Epstein Barr Virus – Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal 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Brief Title

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

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

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 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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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

Condition

Nasopharyngeal Cancer

Intervention

Zometa (zoledronic acid)

Study Arms / Comparison Groups

 Test Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

60

Start Date

September 2005

Completion Date

September 2009

Primary Completion Date

January 2009

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 <= 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

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Li Zhang, Master, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT00697619

Organization ID

CZOL446ECN02

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Collaborators

 Novartis

Study Sponsor

Li Zhang, Master, Principal Investigator, Cancer Center of Sun Yat-Sen University (CCSU)

Verification Date

December 2011