Testing an investigational drug with standard treatment before surgery for rectal cancer.

What we are studying

The purpose of this study is to learn if adding an experimental drug, veliparib (also known as ABT-888), to a usual treatment is better than the usual treatment alone. To be better than the usual treatment, the addition of the experimental drug to the usual treatment needs to shrink more of the cancer than the usual treatment alone. Another purpose of this study is to test the good and bad effects of veliparib when added to the usual treatment. Veliparib may shrink your cancer but it can also cause side effects. Veliparib is not FDA-approved for treating cancer but it is being used in other clinical trials. In this study, veliparib is considered to be experimental.

Who is Eligible

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

Eligibility Criteria

  • Be able to provide informed consent
  • Be diagnosed with adenocarcinoma with a major portion of the tumor intact
  • Be diagnosed with locally advanced Stage II or Stage III rectal cancer
  • Be prescribed a combination of mFOLFOX6 chemotheraphy and chemoradiation with Capecitabine
  • Be scheduled for rectal surgery
  • Be ambulatory and capable of self-care
  • Be able to swallow and retain oral medication
  • Pass screening tests for blood labs and liver/kidney function
  • Not be pregnant or nursing

What is involved

  • Randomization into Group 1 (usual treatment) or Group 2 (usual treatment + Veliparib)
  • Standard of Care treatment for both groups until chemoradiation
  • Additional treatment with oral Veliparib during chemoradiation for patients in Group 2
  • Standard of Care imaging (2 MRIs) to gauge tumor progression.

Compensation

Parking will be validated for study-related visits.

Contact Information

Study Coordinator
Teresa Brady, RN (ADN), CEN
Email
[email protected]
Phone
-4703
Principal Investigator
Edward Levine, M.D.

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