This trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen’s University in Kingston, Ontario.
Oncolytics’ CEO and President Dr. Brad Thompson said in a press release: “Colorectal cancer continues to account for a significant portion of both new cancer cases and deaths in North American men and woman, highlighting the need for ongoing research in this indication. We are grateful to our colleagues at the NCIC CTG for their efforts in completing enrollment in this study in such a timely manner.”
This study is a randomized, open-label, non blinded, phase 2 clinical study to assess Reolysin as a first resort palliative approach to assist those with metastatic or advanced colorectal cancer. The study enrolled 103 patients after a 6-patient safety run was completed. Patients were randomly selected to receive bevacizumab and FOLFOX-6 alone (control arm) or FOLFOX-6 and bevacizumab combined with Reolysin (test arm). Patients received standard doses of bevacizumab and FOLFOX-6 in both arms and on a bi-weekly routine. Subjects in the test arm were treated with intravenous Reolysin, receiving a 3x1010TCID50 dose on days one through five of the 1st, 2nd, 4th, 6th and 8th fourteen-day cycles, and alternate cycles thereafter.
The main goal of the trial is to evaluate the effect of Reolysin when combined with FOLFOX-6 and bevacizumab standard therapy for the progression-free survival of patients with metastatic or advanced colorectal cancer. The trial also intends to determine the toxicity and the tolerability limits of this therapeutic combination; to study other potential indicators of efficacy, including modifications in CEA levels, overall survival and response rate; to explore molecular factors that can have a predictive potential of response, such as KRAS status, by evaluating archival tumor tissue; and to assess overall patient’s quality of life.