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ISRCTN
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ISRCTN29188871
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ClinicalTrials.gov identifier
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Public title
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A phase II, double blind, randomised, dose ranging, safety and efficacy trial of rapid intravenous infusion of Zoledronate versus Aredia in breast cancer patients with osteolytic metastases
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Scientific title
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Acronym
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N/A
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Serial number at source
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C120
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast
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Participants - inclusion criteria
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1. Aged >18 years
2. Histologically confirmed diagnosis of breast cancer
3. At least one osteolytic lesion which measures at least 1 cm in diameter which has not been treated with radiation therapy in the 3 months prior to the start of treatment
4. Metastatic bone lesions confirmed by plain films
5. Life expectancy of at least 10 months
6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of 1-2
7. Satisfactory haematological and blood chemistry values
8. No previous continuous treatment (> four doses) with a bisphosphate, or treatment with a bisphosphate within 3 months of the start of treatment. Treatment with another bisphosphate is not allowed at any time during the trial.
9. Patients for whom orthopaedic surgery to bone or radiation therapy to bone is currently scheduled to treat skeletal disease related to metastatic bone lesions may not enter the trial. A previous history of such procedures is permitted only if the procedure was completed more than 2 weeks prior to the start of treatment
10. Patients who develop hypercalcaemia may be treated with a standard therapy other than a bisphosphate and remain on the trial
11. No recent treatment with cacitonin, mitharmycin or gallium nitrate
12. No previous history of allergic reactions or sensitivity to bisphosphates
13. Normal electrocardiogram (ECG)
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1995
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Anticipated end date
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31/01/1998
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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All patients receive treatment for 9 months.
Patients are randomised to one of four treatment groups:
1. Group A: Zoledronate 0.4 mg in 50 ml normal saline rapid infusion every 4 weeks followed by 250 ml 0.9% normal saline 2 h infusion every 4 weeks.
2. Group B: Zoledronate 2 mg in 50 ml normal saline rapid infusion every 4 weeks followed by 250 ml 0.9% normal saline 2 h infusion every 4 weeks.
3. Group C: Zoledronate 4 mg in 50 ml normal saline rapid infusion every 4 weeks followed by 250 ml 0.9% normal saline 2 h infusion every 4 weeks.
4. Group D: Normal saline, 50 ml rapid infusion every 4 weeks followed by 90 mg Aredia (pamidronate) in 250 ml normal saline 2 h infusion every 4 weeks.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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19/08/2002
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Last edited
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31/01/2008
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Date ISRCTN assigned
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19/08/2002
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