Status:
COMPLETED
Non-small Cell Lung Cancer Registry
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-Small-Cell Lung Cancer
Pleural Effusion, Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00099541
Start Date
November 1 2004
End Date
November 1 2007
Last Update
November 23 2009
Active Locations (101)
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1
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States, 35205
2
Hembree Cancer Center-St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903
3
Pacific Cancer Medical Center Inc.
Anaheim, California, United States, 92801
4
Bay Area Cancer Research Group
Concord, California, United States, 94520