Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activation

Canadian Cancer Trials Group BL.12 -- A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen -- was centrally activated January 27, 2014.

The primary objective of the trial is to compare progression free survival (PFS) between the two arms. Secondary objectives include to:
  • Compare overall survival (OS) between arms;
  • Compare objective response rates (complete or partial response (ORR)) between arms;
  • Compare clinical benefit rate (CBR), as determined by the total number of patients who achieve a complete or partial response (patients with at least one measurable lesion at baseline) plus those patients who have stable disease (SD) for at least 12 weeks (ORR+SD > 12 weeks) between arms (all patients - with or without measurable disease at baseline);
  • Estimate time to response and response duration;
  • Evaluate and compare the nature, severity, and frequency of toxicities, including neuropathy between the two arms;
  • Compare the quality of life between the two arms; and,
  • Determine the incremental cost effectiveness and cost utility ratios for nab-paclitaxel versus paclitaxel.

Target accrual for BL.12 is 199 patients and includes participation of the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). For more information about the trial, please use this link ... http://www.ctg.queensu.ca/trials/genito-urinary/bl12/bl12.html.

Any centres interested in participating should contact Gail McDonald at 613-533-6430 or gmcdonald@ctg.queensu.ca.