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A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00172042
First received: September 13, 2005
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Drug: Zoledronic acid 4 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

  • Kaplan-Meier Estimates for Progression-free Survival [ Time Frame: Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

  • Percentage of Participants With Progression-Free Survival Events [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.


Secondary Outcome Measures:
  • Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months [ Time Frame: Months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

  • Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases [ Time Frame: Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

  • Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.

  • Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE) [ Time Frame: Months 6,12, 18, and 24 ] [ Designated as safety issue: No ]
    Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event

  • Kaplan-Meier Estimates for Overall Survival [ Time Frame: Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]

Enrollment: 437
Study Start Date: March 2005
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic acid
Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
Drug: Zoledronic acid 4 mg
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
Other Name: Zometa®
No Intervention: Control
No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
Drug: Zoledronic acid 4 mg
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
Other Name: Zometa®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)
  • Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
  • Patients must have received primary treatment for their disease and had no progression

Exclusion Criteria:

  • Diagnosed with NSCLC longer than 6 months ago
  • Treatment with other bisphosphonates in past 12 months
  • Presence of metastases

Other protocol-defined inclusion and exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172042

  Show 69 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00172042     History of Changes
Other Study ID Numbers: CZOL446G2419
Study First Received: September 13, 2005
Results First Received: June 16, 2011
Last Updated: August 1, 2011
Health Authority: European Union: European Medicines Agency

Keywords provided by Novartis:
Non-Small-Cell Lung Cancer
Bisphosphonates
Zoledronic acid
Bone metastases
Prevention of bone metastases

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014