None listed
Conditions
Brief 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.
Interventions
Zoledronic acid, 4 mg intravenously monthly for six months
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2.Histologically confirmed diagnosis of non-small cell lung carcinoma (NSCLC) – cytology alone is acceptable 3. Asymptomatic metastatic, previously unirradiated disease to the bone, detected by PET or PET/CT scan 4. Asymptomatic, assessable metastatic disease to previously unirradiated, non-osseous lesions detected by PET or PET/CT scan 5. ECOG performance status of 0-2. NB. Patients who are ECOG 2 must have a reduced PS due to comorbidities rather than their cancer 6. Estimated survival of at least 6 months 7. All potential patients, prior to registration must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists. 8. Women of child bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study drug is ceased.
Exclusion criteria
1. Surgery or chemotherapy within 4 weeks prior to registration onto the study2. Patient planned to start immediate treatment with systemic chemotherapy3. Patient planned to start immediate treatment with palliative radiotherapy to an index lesion, osseous or non-osseous.4. Patient previously received systemic treatment for metastatic non-small cell lung cancer. Prior adjuvant chemotherapy is allowed.5. Treatment with bisphosphonates within the last year6. Initial serum creatinine > 1.5 times the ULN and/or calculated creatinine clearance (by Cockroft-Gault Formula) <60 ml/min and/or known progressive renal disease.7. Corrected serum calcium concentration < 2.00 mmol/L8. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. 9. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) 10. Another disease which could confound evaluation in this study11. Known hypersensitivity to zoledronic acid or other bisphosphonates12. Pregnancy or lactation13. Unlikely to cooperate fully during the study.
Outcome results
None listed