Study Looking at a Different Treatment for Colon Cancer

What we are studying

The purpose of this study is to test the safety and effectiveness of an investigational drug called CPI-613 (“study drug”) when given at different dose levels in combination with Fluorouracil (5-FU) when used to treat colorectal cancer. 5-FU has been approved by the FDA for the treatment of colorectal cancer. CPI-613 is thought to kill cancer cells by turning off their mitochondria. Mitochondria are used by cancer cells to produce energy and are the building blocks needed to make more cancer cells. By shutting off these mitochondria, CPI-613 deprives the cancer cells of energy and other supplies that they need to survive and grow in your body. We want to find out what effects, good and/or bad, CPI-613 has on you and your cancer when given along with 5-FU. We also want to measure the amounts of CPI-613 in your blood after it has been given to you, as well as find the highest dose of CPI-613 that should be used in humans when given along with 5-FU .

Who we are studying

  • Men
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Colorectal cancer that cannot be removed by surgery

What is involved

  • Treatment with study drug for as long as your cancer responds to the treatment

Compensation

None

Contact Information

Study Coordinator
Amy Neal, RN
Email
aneal@wakehealth.edu
Phone
336-713-6912

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.