Phase I/II trial of nano-camptothecin CRLX101 with capecitabine and radiotherapy as neoadjuvant treatment for locally advanced rectal cancer.

Publication Title

Nanomedicine

Authors

Hanna K Sanoff
Dominic H Moon
Dominic T Moore
Jeremiah Boles
Courtney Bui
William Blackstock
Bert H O'Neil
Somasundaram Subramaniam, Swedish Cancer Institute, Seattle, WA.Follow
Autumn J McRee
Cheryl Carlson
Michael S Lee
Joel E Tepper
Andrew Z Wang

Document Type

Article

Publication Date

3-8-2019

Keywords

Camptothecin; Maximum tolerated dose; Nanoparticle; Neoadjuvant; Pathologic complete response; Rectal cancer

Abstract

CRLX101 is a nanoparticle-drug conjugate with a camptothecin payload. We assessed the toxicity and pathologic complete response (pCR) rate of CRLX101 with standard neoadjuvant chemoradiotherapy (CRT) in locally advanced rectal cancer. A single-arm study was conducted with a 3 + 3 dose escalation phase Ib followed by phase II at the maximum tolerated dose (MTD). Thirty-two patients were enrolled with 29 (91%) patients having T3/4 and 26 (81%) N1/2 disease. In phase Ib, no patient experienced a dose limiting toxicity (DLT) with every other week dosing, while 1/9 patients experienced a DLT with weekly dosing. The weekly MTD was identified as 15 mg/m

Clinical Institute

Cancer

Specialty/Research Institute

Oncology