RecruitingPhase 2ACTRN12606000079549

The LoPeZ study

A Phase II clinical study of response to zoledronic acid therapy for bone metastases in patients with non-small cell lung carcinoma as assessed by positron emission tomography (PET)


Sponsor

Peter MacCallum Cancer Centre

Enrollment

14 participants

Start Date

Feb 6, 2006

Study Type

Interventional

Conditions

Summary

This phase II study plans to trial monthly zoledronic acid therapy in patients with PET-detected bone metastases from non-small cell lung cancer, to assess whether zoledronic acid therapy has anti-tumour effects on subsequent PET scans, delays complications related to bony metastases, or is associated with a prolongation of overall or progression-free survival. We plan to study this question in patients with metastatic disease not being immediately commenced on palliative chemotherapy.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a bone-strengthening drug called zoledronic acid (commonly used for osteoporosis and cancer-related bone problems) can also slow the growth of non-small cell lung cancer that has spread to the bones. The drug will be given monthly and its effects will be tracked using PET scans, which show where cancer is active in the body. You may be eligible if: - You are 18 years or older - You have a confirmed diagnosis of non-small cell lung cancer (NSCLC) - Your cancer has spread to the bones but you have no bone pain - Your cancer has also spread to at least one other non-bone site - Your general health is good (ECOG performance status 0–2) - Your expected survival is at least 6 months - You are not about to start chemotherapy or palliative radiotherapy immediately - Women who could become pregnant must use adequate contraception You may NOT be eligible if: - You had surgery or chemotherapy in the last 4 weeks - You are about to start immediate systemic chemotherapy or palliative radiotherapy to a study lesion - You previously received treatment for metastatic NSCLC (prior adjuvant chemo is okay) - You took bisphosphonate drugs in the last year - Your kidney function is significantly reduced - Your calcium level is too low - You have active dental infections or jaw bone problems - You have had dental surgery in the last 6 weeks or have planned dental surgery - You are pregnant or breastfeeding - You have a known allergy to zoledronic acid or other bisphosphonates Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Zoledronic acid, 4 mg intravenously monthly for six months

Zoledronic acid, 4 mg intravenously monthly for six months


Locations(1)

Australia

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ACTRN12606000079549