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Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer

Intervention: Cetuximab (Drug); 5-Fluorouracil (Drug); External Beam Pelvis Radiation Therapy (Radiation)

Phase: Phase 2

Status: Terminated

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Jeffrey Meyerhardt, MD, MPH, Principal Investigator, Affiliation: 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.

Clinical Details

Official title: Phase II Study of Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.

Secondary outcome:

Determine complete resection rate, local recurrence rate, distance recurrence rate, disease free survival and overall survival in this patient population with this treatment.

Characterize toxicity profile of neoadjuvant therapy with cetuximab, 5-FU and radiation in this patient population.

Detailed description:

- 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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


- Coumadin or heparin management for line care of other indications is permitted. The

INR will be monitored weekly in patients taking coumadin. Exclusion Criteria:

- 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

Locations and Contacts

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

South Shore Hospital, Weymouth, Massachusetts, United States

Vanderbilt Medical Center, Nashville, Tennessee, United States

Additional Information

Starting date: January 2008
Last updated: March 12, 2015

Page last updated: August 20, 2015

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