BL12 Trial

Trial Title:

A multicentre randomised phase II trial comparing Nab-paclitaxel to Paclitaxel in patients with advanced urothelial cancer progressing on or after a platinum containing regimen

Trial Acronym:

BL12

Protocol Number:

ANZUP 1401

Trial Design:

Randomised, controlled, open label, two-arm parallel design

Collaborators:

NCIC CTG

ANZ Study Chairs:

Dr. Ben Tran

ANZ Coordinating Centre:

NHMRC CTC

Trial Coordinator:

Anna Walsh

Trial Email:

bl12@ctc.usyd.edu.au

Patient Population:

Adults with advanced urothelial cancer whose disease has progressed while (or soon after) receiving a treatment which included platinum.

Intervention:

Participants will be randomised to receive either:

Arm 1 – Nab-paclitaxel.  Consisting of IV infusion every 3 weeks until disease progression or unmanageable toxicity.

Arm 2 – Paclitaxel.  Consisting of pre-medication and IV infusion every 3 weeks until disease progression or unmanageable toxicity.

Primary Outcome:

To compare progression free survival (PFS) between the two arms

Secondary Outcomes:

To compare overall survival (OS) between arms.

To compare clinical benefit rate (CBR) between arms, as determined by the total number of patients who achieve a complete or partial response plus those patients who have stable disease for at least 12 weeks evaluated using MRI/CT scans.

To estimate time to response and response duration evaluated using MRI/CT scans.

To evaluate and compare the nature, severity, and frequency of toxicities, including neuropathy between the two arms by evaluating adverse events from the time of first treatment.

To compare the quality of life between the two arms.

To determine the incremental cost effectiveness and cost utility ratios using a health utilities assessment questionnaire (EQ-5D questionnaire).

To correlate the expression of tissue markers (at diagnosis) with outcomes and response. Diagnostic tumor tissue will be analysed to assess this outcome.

To assess genetic polymorphisms that may impact on response or toxicity to the taxanes. A whole blood sample is collected for this assessment.

To assess the effect modification of clinico-demographic factors using health and demographics questionnaires

Status:

Closed to recruitment

Sites Recruiting:

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