Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000079549
Ethics application status
Approved
Date submitted
6/02/2006
Date registered
23/02/2006
Date last updated
23/02/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The LoPeZ study
Scientific title
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)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic non-small cell lung carcinoma with bony metastases 1043 0
Condition category
Condition code
Cancer 1120 1120 0 0
Lung - Non small cell
Cancer 1121 1121 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zoledronic acid, 4 mg intravenously monthly for six months
Intervention code [1] 886 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1497 0
The primary endpoint is the Visual metabolic response rate in asymptomatic non-osseous lesions
Timepoint [1] 1497 0
At 1 and 3 months, as determined by changes from baseline on [18F]-FDG PET/CT scans
Secondary outcome [1] 2694 0
The response of asymptomatic osseous metastases.
Timepoint [1] 2694 0
At 1 and 3 months, as determined by changes from baseline in [18F]-FDG PET/CT scans, according to visual criteria.
Secondary outcome [2] 2695 0
The response of asymptomatic non-osseous and osseous metastases.
Timepoint [2] 2695 0
At 1 and 3 months, as determined by changes from baseline in [18F]-FDG PET/CT scans, according to changes in standardised uptake value (SUV).
Secondary outcome [3] 2696 0
The objective response rate in asymptomatic non-osseous metastases, as determined by RECIST criteria.
Timepoint [3] 2696 0
Secondary outcome [4] 2697 0
Risk and nature of skeletal related events
Timepoint [4] 2697 0
Secondary outcome [5] 2698 0
Safety over the six months on study
Timepoint [5] 2698 0
Secondary outcome [6] 2699 0
Overall and progression-free survival.
Timepoint [6] 2699 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1225 0
Commercial sector/Industry
Name [1] 1225 0
Novartis pharmaceuticals
Country [1] 1225 0
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1082 0
None
Name [1] 1082 0
None
Address [1] 1082 0
Country [1] 1082 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36395 0
Address 36395 0
Country 36395 0
Phone 36395 0
Fax 36395 0
Email 36395 0
Contact person for public queries
Name 10075 0
Dr Linda Mileshkin
Address 10075 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 10075 0
Australia
Phone 10075 0
+61 3 96561697
Fax 10075 0
+61 3 96561408
Email 10075 0
Linda.Mileshkin@petermac.org
Contact person for scientific queries
Name 1003 0
Bev McClure
Address 1003 0
Centre for Biostatistics and Clinical Trials
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 1003 0
Australia
Phone 1003 0
+61 3 96561266
Fax 1003 0
+61 3 96561420
Email 1003 0
Bev.McClure@petermac.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.