Clinical Research Papers:
A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209
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Bernhard Josef Eigl1, Kim Chi1, Dongsheng Tu2, Sebastien J. Hotte3, Eric Winquist4, Christopher M. Booth5, Christina Canil6, Kylea Potvin4, Richard Gregg2, Scott North7, Muhammad Zulfiqar1, Susan Ellard8, Joseph Dean Ruether9, Lyly Le10, A. Saranya Kakumanu11, Mohammad Salim12, Alison L. Allan4, Harriet Feilotter2, Ashley Theis2 and Lesley Seymour2
1BC Cancer Agency, Vancouver, BC, Canada
2Canadian Cancer Trials Group, Kingston, ON, Canada
3Juravinski Cancer Centre, Hamilton, ON, Canada
4London Health Sciences Centre, London, ON, Canada
5Cancer Centre of Southeastern Ontario, Kingston, ON, Canada
6Ottawa Regional Cancer Center, Ottawa, ON, Canada
7Cross Cancer Centre, Edmonton, AB, Canada
8BC Cancer Agency, Kelowna, BC, Canada
9Tom Baker Cancer Centre, Calgary, AB, Canada
10BC Cancer Agency, Surrey, BC, Canada
11Cancer Care Manitoba, Winnipeg, MB, Canada
12Regina Cancer Centre, Regina, SK, Canada
Bernhard Josef Eigl, email: [email protected]
Keywords: prostate cancer; oncolytic viruses; chemotherapy; clinical trial
Received: October 12, 2017 Accepted: January 02, 2018 Published: January 17, 2018
Background: Pelareorep is an oncolytic virus with activity in many cancers including prostate. It has in vitro synergism with microtubule-targeted agents. We undertook a clinical trial evaluating pelareorep in mCRPC patients receiving docetaxel.
Patients and Methods: In this randomized, open-label phase II study, patients received docetaxel 75mg/m2 on day 1 of a 21-day cycle and prednisone 5mg twice daily, in combination with pelareorep (arm A) or alone (arm B). The primary endpoint was 12 weeks lack of disease progression rate (LPD).
Results: Eighty-five pts were randomized. Median age was 69, ECOG performance status was 0/1/2 in 31%/66%/3% of patients. Bone/regional lymph node/liver metastases were present in 98%/24%/6%. The median prognostic score was slightly higher in Arm A (144 vs. 129 p= 0.005). Adverse events were as expected but more prevalent in arm A. The 12-week LPD rate was 61% and 52.4% in arms A/B (p=0.51). Median survival was 19.1 on Arm A and 21.1 months on Arm B (HR 1.83; 95% CI 0.96 to 3.52; p=0.06). No survival benefit of pelareorep was found.
Conclusion: Pelareorep with docetaxel was tolerable with comparable LPD in both arms but response and survival were inferior and so this combination does not merit further study.
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