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| A randomised two-arm, prospective, multi-centre, open-label phase III trial comparing the activity and safety of a weekly versus a three-weekly paclitaxel treatment schedule in patients with advanced or metastatic breast cancer |
| ISRCTN | ISRCTN52817670 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised two-arm, prospective, multi-centre, open-label phase III trial comparing the activity and safety of a weekly versus a three-weekly paclitaxel treatment schedule in patients with advanced or metastatic breast cancer |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | BR0201 |
| Study hypothesis |
Primary objectives:
1. To compare the antitumour efficacy of weekly versus three-weekly paclitaxel as determined by the time to disease progression 2. To study polymorphisms in the genes responsible for paclitaxel metabolism and link these to response rates and toxicity Secondary objectives: 1. To compare the toxicity of weekly versus three-weekly paclitaxel 2. To compare the response rate of weekly versus three-weekly paclitaxel 3. To compare overall survival in patients receiving weekly versus three-weekly paclitaxel 4. To compare quality of life in patients receiving weekly versus three-weekly paclitaxel |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Breast cancer |
| Participants - inclusion criteria |
1. Histologically proven breast cancer
2. Locally advanced or metastatic disease 3. Presence of measurable or evaluable lesions 4. Prior treatment with anthracyclines (either in the adjuvant setting or for metastatic disease) or contraindication to anthracyclines 5. Aged 18 years or greater 6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 7. Adequate haematological, renal and hepatic function 8. Written informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Anticipated start date | 16/09/2002 |
| Anticipated end date | 01/01/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 600 |
| Interventions |
Arm 1: Paclitaxel (90 mg/m^2 intravenous [IV] over 1 hour on day 1 every week for 12 cycles)
Arm 2: Paclitaxel (175 mg/m^2 IV over 3 hours on day 1 every 3 weeks for 6 cycles) |
| Primary outcome measure(s) |
1. Antitumour efficacy, as determined by the time to disease progression
2. Polymorphisms in the genes responsible for paclitaxel metabolism, response rates and toxicity |
| Secondary outcome measure(s) |
1. Toxicity
2. Response rate 3. Overall survival 4. Quality of life |
| Sources of funding | Anglo Celtic Cooperative Oncology Group (UK) - supported by an educational grant from Bristol-Myers Squibb Pharmaceuticals Limited |
| Trial website | |
| Publications | |
| Contact name | Dr M Verrill |
| Address |
University of Newcastle Department of Oncology
Newcastle General Hospital Westgate Road |
| City/town | Newcastle Upon Tyne |
| Zip/Postcode | NE4 6BE |
| Country | United Kingdom |
| Tel | +44 (0)191 219 4252 |
| Fax | +44 (0)191 273 4867 |
| mark.verrill@ncl.ac.uk | |
| Sponsor | Anglo Celtic Cooperative Oncology Group (UK) |
| Address |
SCTN Central Office
Information & Statistics Division Trinity Park House South Trinity Road |
| City/town | Edinburgh |
| Zip/Postcode | EH5 3SQ |
| Country | United Kingdom |
| Tel | +44 (0)131 551 8363 |
| Fax | +44 (0)131 552 4085 |
| joanna.dunlop@isd.csa.scot.nhs.uk | |
| Sponsor website: | http://www.amgen.com |
| Date applied | 15/10/2002 |
| Last edited | 19/05/2008 |
| Date ISRCTN assigned | 15/10/2002 |
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