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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Progression free survival
Time frame: 24 months
Response rate
To investigate additional potential measures of efficacy including Objective response rate, overall survival (OS) and CTC counts.
Time frame: 24 months
Tumour and tissue response of potential molecular factors
Potential molecular factors which may be prognostic or predictive of response by assessment of archival tumour tissue, CTCs, and serial blood samples
Time frame: 24 months
Number of patients with adverse events
To determine the tolerability and toxicity of reolysin and paclitaxel when given in combination.
Time frame: 24 months
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Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada