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Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00762346
First Posted: September 30, 2008
Last Update Posted: December 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
  Purpose
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.

Condition Intervention Phase
Non Small Cell Lung Cancer Bone Metastases High NTX Level Drug: zometa Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

Resource links provided by NLM:


Further study details as provided by Li Zhang, Sun Yat-sen University:

Primary Outcome Measures:
  • Skeleton-related event [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • OS [ Time Frame: 2 years ]

Enrollment: 156
Study Start Date: September 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: zometa
zometa 4mg i.v. every 4 weeks for up to 2 years

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray, CT or others)
  • NTX > 50nM BCE/mM creatinine
  • Life expectancy > 6 M
  • ECOG <= 2
  • Signed ICF

Exclusion Criteria:

  • Women who are pregnant or in lactation
  • Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
  • Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
  • Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762346


Locations
China, Guangdong
cancer center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Novartis
Investigators
Principal Investigator: Li Zhang, MD Sun Yat-sen University
  More Information

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00762346     History of Changes
Other Study ID Numbers: CZOL446ECN06T
First Submitted: September 29, 2008
First Posted: September 30, 2008
Last Update Posted: December 10, 2013
Last Verified: December 2011

Keywords provided by Li Zhang, Sun Yat-sen University:
non small cell lung cancer
NTX
zometa

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs