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Non-small Cell Lung Cancer Registry

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ClinicalTrials.gov Identifier: NCT00099541
Recruitment Status : Completed
First Posted : December 16, 2004
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Pleural Effusion, Malignant Drug: zoledronic acid Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2004
Estimated Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

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 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

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): NCT00099541


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00099541     History of Changes
Other Study ID Numbers: CZOL446EUS99
US99
Z-NEXT
First Posted: December 16, 2004    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

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