Status: Closed
Activation Date: 2012JUN11
Closing Date: 2015FEB12
Phase: II
Description: A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.
Eligibility: Patients with a histological diagnosis of metastatic colorectal adenocarcinoma. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. No prior chemotherapy for metastatic disease. Prior adjuvant fluropyrimidine based therapy is permitted >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function. No neuropathy > grade1
Objective: 1. To evaluate the effect of reolysin in combination with standard FOLFOX6 chemotherapy of the progression free survival of patients with advanced or metastatic colorectal cancer. 2a. To determine the tolerability and toxicity of reolysin and FOLFOX6/Bevacizumab when given in combination. 2b. To investigate additional potential measures of efficacy including:change in CEA levels; objective response rate; evaluate the effect of both treatments on overall survival (OS) 2c.To explore potential molecular factors that may be prognostic or predictive of response by assessment of archival tumour tissue and serial blood samples 2d.To explore the Quality of Life (as measured by the EORTC QLQC30)
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to discover if adding reolysin to standard chemotherapy (FOLFOX6/Bevacizumab) is as effective as standard chemotherapy (FOLFOX6/Bevacizumab) alone by looking at changes in CEA levels and amount of disease. On both arms the FOLFOX6 /Bevacizumab are given as a combination of drugs which are given together on day one, and then followed by a continuous infusion through a portable pump over the next 46 hours, also every 2 weeks. On the experimental arm, Reolysin will be given by intravenous injection over 1 hr on days 1-5 for cycles 1,2,4 6, and every second cycle after that, after the FOLFOX6/Bevacizumab infusion. (one cycle is 2 weeks) Side-effects and safety of reolysin and FOLFOX6/Bevacizumab in combination will be monitored. Additional research will investigate tissue samples from previously removed colorectal tissue.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I210 | 109 | 75 | 98 | 103 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I210 | 109 | 1 | 30 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I210 | 109 | 57 | 0 | 0 | 0 | 52 | 60 | 1 | 0 |