Phase I Study of Pre-operative Continuous 5-FU, and Sorafenib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma
Participants' study regimen will include 5 ½ weeks of radiation. Radiation sessions will be
daily, Monday through Friday, except for holidays. 5-FU will be delivered at a dose of 225
mg/m² daily through a catheter in a large vein continuously until the last day of radiation.
In addition, sorafenib will be taken by mouth twice daily every day until the last day of
radiation. The dose of sorafenib participants may receive will be one of the following: 200
mg every other day, 200 mg daily, 400 mg daily, or 800 mg daily. Following completion of
this phase of the study, participants will receive no study drug or radiation for one month.
At 4 to 5 weeks after stopping study drug and radiation, participants will have another CT
scan or MRI to assess their cancer. About 6 to 8 weeks after the end of radiation,
participants will undergo surgery and every effort will be made to remove the tumor. The
surgery will occur just as it would if participants were not in the study, except that a
portion of their tumor obtained during surgery will be used for research biomarker testing
(as described in the consent form).
Approximately 6 -10 weeks after participants' surgery, when they have adequately healed,
they may receive additional chemotherapy at their study doctor's discretion.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
To determine maximally tolerated dose of sorafenib when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinoma
Start of treatment through end of follow up - average of 21 weeks
Richard Kim, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|