Phase I/II trial of nano-camptothecin CRLX101 with capecitabine and radiotherapy as neoadjuvant treatment for locally advanced rectal cancer.
Camptothecin; Maximum tolerated dose; Nanoparticle; Neoadjuvant; Pathologic complete response; Rectal cancer
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
Sanoff, Hanna K; Moon, Dominic H; Moore, Dominic T; Boles, Jeremiah; Bui, Courtney; Blackstock, William; O'Neil, Bert H; Subramaniam, Somasundaram; McRee, Autumn J; Carlson, Cheryl; Lee, Michael S; Tepper, Joel E; and Wang, Andrew Z, "Phase I/II trial of nano-camptothecin CRLX101 with capecitabine and radiotherapy as neoadjuvant treatment for locally advanced rectal cancer." (2019). Articles, Abstracts, and Reports. 1317.