Non-small Cell Lung Cancer Registry

Phase 4

Completed

• Conditions: Non-Small-Cell Lung Cancer; Pleural Effusion, Malignant

• Registration Number: NCT00099541
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-12-15
• Study First Submitted QC: 2004-12-15
• Study First Posted: 2004-12-16
• Study Completion: 2007-11
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-20
• Last Update Posted: 2009-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (101)

Birmingham Hematology and Oncology Associates; 🇺🇸 Birmingham, Alabama, United States

Hembree Cancer Center-St. Edward Mercy Medical Center; 🇺🇸 Fort Smith, Arkansas, United States

Pacific Cancer Medical Center Inc.; 🇺🇸 Anaheim, California, United States

Bay Area Cancer Research Group; 🇺🇸 Concord, California, United States

Fresno Hem/Onc Medical Group; 🇺🇸 Fresno, California, United States

Beaver Med Group; 🇺🇸 Highland, California, United States

Redwood Regional Medical Group; 🇺🇸 Santa Rosa, California, United States

Stockton Hem. Onc.; 🇺🇸 Stockton, California, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Front Range Cancer Specialists; 🇺🇸 Fort Collins, Colorado, United States

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