Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
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ClinicalTrials.gov Identifier: NCT00611858
Recruitment Status :
First Posted : February 11, 2008
Last Update Posted : February 7, 2017
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given with 5-FU and radiation therapy. The epidermal growth factor (EGF) receptor, which is found in rectal cancer, is a specific part of the cancer that is felt to encourage tumor growth. Cetuximab targets and blocks the EGF receptor and has been shown to be safe and effective in treating colorectal cancer and head and neck cancers.
Prior to the first dose of cetuximab, participants will undergo a sigmoidoscopy with biopsy for research purposes as well collection of blood samples. These tests will be repeated between days 16 and 21.
After treatment begins, participants will undergo the following every week; history and physical exam; vital signs; blood tests.
On treatment weeks 1, 2 and 3: cetuximab is given once a week. On weeks 4 through 9: cetuximab is given weekly; continuous infusion of 5-FU will begin on day 22; treatment with radiation therapy Monday through Friday.
It is recommended that the participant undergo surgery 4 to 8 weeks after completion of therapy to attempt to remove the tumor.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically confirmed adenocarcinoma of the rectum that begins within 15cm of the anal verge as determined by sigmoidoscopy and/or colonoscopy, with no evidence of distant metastatic disease. A complete colonoscopy to the cecum is recommended prior to initiating protocol therapy.
Staging with transrectal ultrasound or endorectal coil MRI to confirm clinical stage of T3 or T4 or lymph node positive rectal adenocarcinoma
Tumor is K-ras wildtype by method of choice at respective institution (testing codons 12 and 13)
Performance status: ECOG less than or equal to 2
18 years of age or older
No evidence of metastatic disease by abdominal/pelvic CT and chest imaging
Adequate bone marrow, renal,and hepatic function as outlined in protocol
All patients will be evaluated by a surgeon and considered a candidate for definitive surgery
Coumadin or heparin management for line care of other indications is permitted. The INR will be monitored weekly in patients taking coumadin.
Prior treatment for this malignancy
Prior history of pelvic radiation therapy
Prior history of 5-FU based or EGFR receptor inhibitor therapy
Prior history of an allergic reaction to a monoclonal antibody
Uncontrolled serious medical or psychiatric illness
Significant history of uncontrolled cardiac disease
Sexually active women of childbearing potential must use an effective method of birth control during the course of the study
Unwilling to agree to pre and post-cetuximab sigmoidoscopy and biopsy