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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00611858
Recruitment Status : Terminated (Slow accrual)
First Posted : February 11, 2008
Last Update Posted : February 7, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Cetuximab Drug: 5-Fluorouracil Radiation: External Beam Pelvis Radiation Therapy Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
Study Start Date : January 2008
Primary Completion Date : July 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Cetuximab
    Given once a week for 9 weeks
    Drug: 5-Fluorouracil
    Given by continuous infusion for weeks 4 through 9
    Other Name: 5-FU
    Radiation: External Beam Pelvis Radiation Therapy
    Monday through Friday beginning after the 2nd sigmoidoscopy and biopsy is completed

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Determine complete resection rate, local recurrence rate, distance recurrence rate, disease free survival and overall survival in this patient population with this treatment. [ Time Frame: 3 years ]
  2. Characterize toxicity profile of neoadjuvant therapy with cetuximab, 5-FU and radiation in this patient population. [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 surgery
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611858


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
South Shore Hospital
Weymouth, Massachusetts, United States
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Bristol-Myers Squibb
Investigators
Principal Investigator: Jeffrey Meyerhardt, MD, MPH Dana-Farber Cancer Institute
More Information

Responsible Party: Jeffrey A. Meyerhardt, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00611858     History of Changes
Other Study ID Numbers: 07-297
BMS CA225302
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute:
5-FU
cetuximab
radiation
adenocarcinoma of the rectum
neoadjuvant therapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs