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)
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| ClinicalTrials.gov Identifier: NCT00172042 |
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Recruitment Status :
Completed
First Posted : September 15, 2005
Results First Posted : July 19, 2011
Last Update Posted : May 4, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small-Cell Lung Cancer | Drug: Zoledronic acid 4 mg | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 437 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | March 2005 |
| Actual Primary Completion Date : | May 2010 |
| Actual Study Completion Date : | June 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Zoledronic acid
| Arm | Intervention/treatment |
|---|---|
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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.
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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® |
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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.
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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® |
Primary Outcome Measures :
- Progression-Free Survival [ Time Frame: Up to 24 months ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00172042
Locations
Show 69 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00172042 |
| Other Study ID Numbers: |
CZOL446G2419 |
| First Posted: | September 15, 2005 Key Record Dates |
| Results First Posted: | July 19, 2011 |
| Last Update Posted: | May 4, 2015 |
| Last Verified: | April 2015 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Non-Small-Cell Lung Cancer Bisphosphonates Zoledronic acid Bone metastases Prevention of bone metastases |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Neoplastic Processes Pathologic Processes Zoledronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |