Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out what effects, good and/or bad, the combination of
the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine,
radiation, and the study drug kill cancer cells in different ways. Giving these treatments
together may make your cancer shrink or slow down its growth more than it would if you got
treated with capecitabine and radiation alone.
This is a Phase I drug study of ganetespib given together with capecitabine and radiation in
patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not
approved by the Food and Drug Administration (FDA). The other two, capecitabine and
radiation, are approved by FDA for use in rectal cancer.
In this study, the investigators will test different dosages of the "investigational"
(experimental) drug, called ganetespib (the study drug). The study drug is "investigational"
because it is not approved by the FDA for use. The study drug has been previously tested in
humans. The study uses a well-established process of slowly increasing drug dosage to
determine the highest dosage that can be given without causing serious side effects. In
addition, the study will help researchers to determine what the side effects and drug
interactions might be.
The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and
capecitabine with radiation work in your body (for example how long the drugs last in your
body.)