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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00762346
• Collaborator: Novartis (Industry)
• Enrollment: 156
• Location: 1
• Arm: 1
• Duration (Months): 53.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer; Bone Metastases; High NTX Level	Drug: zometa	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: N/A
• 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
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: zometa; zometa 4mg i.v. every 4 weeks for up to 2 years

Outcome Measures

Primary Outcome Measures

1. Skeleton-related event [2 years]

Secondary Outcome Measures

1. OS [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT00762346
• Other Study ID Numbers: CZOL446ECN06T
• First Posted: Sep 30, 2008
• Last Update Posted: Dec 10, 2013
• Last Verified: Dec 1, 2011

• Keywords provided by Li Zhang, Profressor, 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; Zoledronic Acid

Study Results

No Results Posted as of Dec 10, 2013