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Clinical Trials/NCT00099541
NCT00099541CompletedPhase 4

A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis

Novartis Pharmaceuticals201 sites in 1 country300 target enrollmentStarted: November 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
300
Locations
201
Primary Endpoint
Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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

Investigators

Sponsor Class
Industry

Study Sites (201)

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