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Non-small Cell Lung Cancer Registry

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099541
First received: December 15, 2004
Last updated: November 20, 2009
Last verified: November 2009
History of Changes
  Purpose

This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Pleural Effusion, Malignant
 Drug: zoledronic acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
  • Group 2: Observational

Secondary Outcome Measures:
  • Patients with an SRE will be evaluated for:
  • Time from stage IIIB/IV NSCLC diagnosis to progression to bone
  • Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
  • The effect of serum NTX levels on the development of skeletal events (SREs), and
  • Overall survival
  • Group 2: Obervational

Estimated Enrollment: 300
Study Start Date: November 2004
Estimated Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
  • Unresectable Stage IIIB with pleural effusion or stage IV NSCLC
  • ECOG performance status of 0 or 1

Exclusion Criteria:

  • Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid)
  • Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
  • Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
  • Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
  • Abnormal renal function or creatinine clearance
  • Unstable brain metastasis
  • Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
  • Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099541

  Show 101 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: L. Lacerna, MD Novartis Pharmaceuticals
  More Information

Additional Information:
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00099541     History of Changes
Other Study ID Numbers: CZOL446EUS99, US99, Z-NEXT
Study First Received: December 15, 2004
Last Updated: November 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Lung Cancer
Bone Metastases
Bone Markers
NTX
 zoledronic acid
Registry
Unresectable Stage IV Non Small-cell Lung Cancer (NSCLC)
Unresectable Stage IIIB NSCLC with Pleural Effusion

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Effusion
Pleural Effusion, Malignant
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013