Phase I/II trial of Nano-camptothecin CRLX101 with Capecitabine and radiotherapy as neoadjuvant treatment for locally advanced rectal Cancer.

@article{Sanoff2019PhaseIT,
  title={Phase I/II trial of Nano-camptothecin CRLX101 with Capecitabine and radiotherapy as neoadjuvant treatment for locally advanced rectal Cancer.},
  author={Hanna K Sanoff and Dominic H. Moon and Dominic T. Moore and Jeremiah Boles and Courtney L. Bui and William A Blackstock and Bert H O'Neil and Somasundaram Subramaniam and Autumn J. McRee and Christine E. Carlson and Michael S Lee and Joel E Tepper and Andrew Z. Wang},
  journal={Nanomedicine : nanotechnology, biology, and medicine},
  year={2019}
}
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… CONTINUE READING
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