What we are studying
This study is designed to test an investigational new drug called CRLX101 in combination with standard chemotherapy capecitabine and radiation. This combination of treatments is known as “chemoradiotherapy”.
CRLX101 is investigational and has not been approved by the US Food and Drug Administration (FDA) for treatment of your type of cancer. In laboratory studies, camptothecin has been shown to be very effective at inhibiting the growth of rectal cancer when combined with standard therapeutic doses of radiation and the drug capecitabine.
This study has two parts. The first part of the study or “phase Ib” is designed to determine the best or “optimum” dose of CRLX101to use in combination with standard anti-cancer therapies capecitabine and radiation in the second part or “phase II” of the study.
The second portion of the study or “Phase II” is for patients that are scheduled to have surgery to remove their tumor following this chemoradiotherapy, and will determine how effective the optimum dose of CRLX101 is when combined with capecitabine and radiation before surgical removal of the tumor. You must be a good candidate for surgical removal or “resection” of the tumor to participate in the phase II portion of this study.