Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer
Status:
Terminated
Trial end date:
2019-06-25
Target enrollment:
Participant gender:
Summary
This trial will enroll patients with locally advanced rectal cancer (resectable and
non-resectable).The phase Ib dose escalation portion of trial is designed to determine the
maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies
capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP)
formulation of camptothecin. These results will determine the recommended phase II dose
(RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to evaluate
the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and radiation
therapy prior to surgery.