A Study of Reolysin For Patients With Advanced/Metastatic Breast Cancer
Researchers doing this study want to evaluate the side effects of Reolysin when given together with paclitaxel. As these drugs have not been given together before, 6-9 patients will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer|
- Progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]To investigate additional potential measures of efficacy including Objective response rate, overall survival (OS) and CTC counts.
- Tumour and tissue response of potential molecular factors [ Time Frame: 24 months ] [ Designated as safety issue: No ]Potential molecular factors predictive of response by assessment of archival tumour tissue and CTCs (including EGFR and KRAS status) and serial blood samples
- Number of patients with adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]To determine the tolerability and toxicity of reolysin and paclitaxel when given in combination.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Paclitaxel plus Reolysin
Paclitaxel given weekly on days 1, 8, 15 every 4 weeks plus reolysin days 1, 2, 8, 9, 15 and 16.
|Drug: Paclitaxel Drug: Reolysin|
Active Comparator: Paclitaxel
Paclitaxel given weekly on days 1, 8 and 15 every 4 weeks.
The purpose of the randomized part of this study is to find out if giving Reolysin in combination with paclitaxel can offer better results than standard therapy with paclitaxel.
|Contact: Lesley Seymourfirstname.lastname@example.org|
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior||Recruiting|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Contact: Susan Ellard 250 712-3900 ext 686657|
|BCCA - Vancouver Cancer Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: Karen Gelmon 604 877-6000 ext 2032|
|BCCA - Vancouver Island Cancer Centre||Recruiting|
|Victoria, British Columbia, Canada, V8R 6V5|
|Contact: Vanessa Bernstein 250 519-5571|
|Juravinski Cancer Centre at Hamilton Health Sciences||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Sukhbinder Dhesy-Thind 905 387-9495 ext 64431|
|Cancer Centre of Southeastern Ontario at Kingston||Recruiting|
|Kingston, Ontario, Canada, K7L 5P9|
|Contact: Mihaela Mates 613 549-2631 ext 4503|
|Ottawa Health Research Institute - General Division||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Susan Dent 613 737-7700 ext 70167|
|McGill University - Dept. Oncology||Recruiting|
|Montreal, Quebec, Canada, H2W 1S6|
|Contact: Nathaniel Bouganim 514 398-8307|
|Allan Blair Cancer Centre||Recruiting|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Contact: Vamsee Torri 306 766-2691|
|Study Chair:||Vanessa Bernstein||BCCA - Vancouver Island Centre|
|Study Chair:||Susan Ellard||BCCA-Cancer Ctr., Southern Interior|