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

Phase 2
18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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

- 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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jeffrey Meyerhardt, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2008

Completion Date:

December 2013

Related Keywords:

  • Rectal Cancer
  • 5-FU
  • cetuximab
  • radiation
  • adenocarcinoma of the rectum
  • neoadjuvant therapy
  • Rectal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
South Shore Hospital South Weymouth, Massachusetts  02190
Vanderbilt Medical Center Nashville, Tennessee  37232-2765