Non-small Cell Lung Cancer Registry

Completed · Phase 4

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

In brief

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.

Key facts

Study ID

NCT00099541

Run by

Novartis Pharmaceuticals

People needed

300

Starts

2004-11-01

Expected to finish

2007-11-01

Last updated by the study team

2009-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Greeley Medical Clinic — Greeley, Colorado, United States
• Western Hematology/Oncology — Lakewood, Colorado, United States
• Hematology Oncology PC — Stamford, Connecticut, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Gainesville Hematology Oncology Associates — Gainesville, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Center for Cancer Care & Research — Lakeland, Florida, United States
• Lake Heart & Cancer Center — Leesburg, Florida, United States
• Melbourne Internal Medicine Assoc (MIMA) Century Research — Melbourne, Florida, United States
• Pasco Pinellas Cancer Center — New Port Richey, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Mid- Florida Hematology & Oncology Centers, PA — Orange City, Florida, United States
• Space Coast Medical — Titusville, Florida, United States
• Vero Beach Hematology/Oncology — Vero Beach, Florida, United States
• Hematology & Oncology of N.E. GA — Athens, Georgia, United States
• Birmingham Hematology and Oncology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.