Pre-operative 5-Fluorouracil (5-FU) and Sorafenib With External Radiation in Locally Advanced Rectal Cancer
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to find the maximum tolerable dose of sorafenib when
administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about
whether these drugs, along with radiation, can help people with rectal cancer when given
before surgery. 5-FU and radiation are both approved by the US Food and Drug Administration
(FDA) for use in people with rectal cancer.
The investigators will utilize a standard 3 + 3 phase I study design. In the phase I part of
the study, the investigators will attempt dose escalation of sorafenib in combination with
standard infusional 5-FU and external beam at standard doses. Clinical staging should be done
by endorectal ultrasound (ERUS) and/or pelvic magnetic resonance imaging (MRI) for T and N
stage; chest and abdomen computed tomography (CT) for staging of metastatic disease; undergo
sigmoidoscopy and/or colonoscopy done by crude odds ratios (CORS); biopsy is taken for
diagnosis and extra is sent for tissue bank. At the maximum tolerated dose (MTD) of sorafenib
we will expand the cohort to 6 more patients to further evaluate toxicity profile and
efficacy.
Phase:
Phase 1
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute