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

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Trial Conditions
  • Non-Small-Cell Lung Cancer
  • Pleural Effusion, Malignant
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • L. Lacerna, MD
Facilities
  • Holy Family Hospital - Completed
Trial Interventions
Drug
  • zoledronic acid
Physician Researcher

Investigator Name:

  • L. Lacerna, MD

Other Information

Sponsor: Novartis Pharmaceuticals
Phase: Phase 4
Trial ID: NCT00099541
Volunteers:  Not Accepting Healthy Volunteers

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