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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
December 15, 2004
November 20, 2009
November 2004
Not Provided
  • 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
Not Provided
Complete list of historical versions of study NCT00099541 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Non-small Cell Lung Cancer Registry
A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Small-Cell Lung Cancer
  • Pleural Effusion, Malignant
Drug: zoledronic acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
November 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00099541
CZOL446EUS99
US99
Z-NEXT
Not Provided
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Not Provided
Study Chair: L. Lacerna, MD Novartis Pharmaceuticals
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP