|
Welcome
|
|
30 July 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
|
| [ ...Back to search results ] | [ Print-friendly version ] |
| 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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN29188871 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | C120 |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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) |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Anticipated start date | 01/01/1995 |
| Anticipated end date | 31/01/1998 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123 Lincoln's Inn Fields London United Kingdom WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN29188871 |
| Date last extracted from ISRCTN register | 17/04/2008 |
|
|
|
|
|
| © 2010 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | |
|
|
|
|