Pre-op Rectal ChemoRad +/- Cetuximab
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Cetuximab; 5-fluorouracil; Pelvic irradiation
Intervention MeSH terms: Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out what effects (good and bad) cetuximab has
      on rectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        Note: Please see Section 8.1 for the necessary "Prestudy Assessments".

        A patient will be eligible for inclusion in this study if s/he meets all of the following
        criteria:

          -  Has a histologically confirmed diagnosis of newly diagnosed adenocarcinoma of the
             rectum (tumor within 15 cm of the anal verge). Location of tumor (lower 1/3rd vs.
             middle or upper 1/3rd) and pre-treatment nodal status (N0 vs. N1 or N2) will be
             recorded in the eCRF. Patients with only non-measurable disease are eligible as long
             as they meet the other disease requirements in this criterion as well as all other
             eligibility criteria.

          -  Has tumor that is locally advanced (T3/T4 or lymph node positive) by preoperative
             assessment with CT or MRI imaging or transrectal ultrasonography.

          -  Has no evidence of distant metastases by radiographic staging

          -  Has an ECOG Performance Status (PS) 0-1

          -  Is greater than 18 years of age

          -  Has adequate marrow and organ system function as assessed by the following lab values:

        White blood cell (WBC) count See protocol for specific details Absolute neutrophil count
        (ANC) See protocol for specific details Hemoglobin See protocol for specific details Total
        bilirubin See protocol for specific details AST and ALT See protocol for specific details
        Serum creatinine See protocol for specific details Platelet count See protocol for specific
        details

          -  Sexually active women of childbearing potential must use an effective method of birth
             control during the course of the study, in a manner such that risk of failure is
             minimized.

        Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the
        importance of avoiding pregnancy during trial participation and the potential risk factors
        for an unintentional pregnancy. In addition, men enrolled on this study should understand
        the risks to any sexual partner of childbearing potential and should practice an effective
        method of birth control.

        All WOCBP MUST have a negative pregnancy test within 3 weeks prior to registration
        (confirmed within 7 days prior to first receiving investigational product). If the
        pregnancy test is positive, the patient must not receive investigational product and must
        not be enrolled in the study.

        In addition, all WOCBP should be instructed to contact the Investigator immediately if they
        suspect they might be pregnant (eg, missed or late menstrual period) at any time during
        study participation.

        The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a
        patient participating in the study.

          -  Has signed a Patient Informed Consent Form

          -  Has signed a Patient Authorization Form

        Exclusion Criteria:

          -  A patient will be excluded from this study if s/he meets any of the following
             criteria:

          -  Has another disease similar to one being studied (ie, colon cancer)

          -  Has evidence of distant metastases by radiographic staging

          -  Has had prior treatment for the current disease

          -  Has had prior stem cell or bone marrow transplant or any organ transplant with the
             exception of corneal transplant or cadaver bone graft

          -  Has a history of hypersensitivity to any of study treatments

          -  Has had a prior severe infusion reaction to a monoclonal antibody

          -  Has received prior therapy, at any time, which specifically and directly targets the
             EGFR pathway

          -  Has a significant history of uncontrolled cardiac disease; ie, uncontrolled
             hypertension, unstable angina, recent myocardial infarction (within prior 6 months),
             uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection
             fraction

          -  Has evidence of CNS involvement (CNS imaging is not required for study enrollment
             unless clinically suspected CNS disease is present.)

          -  Has a serious uncontrolled intercurrent medical or psychiatric illness, including
             serious infection or Gilbert's Syndrome

          -  Has a history of other malignancy within the last 5 years (except cured basal cell
             carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the
             diagnosis or assessment of any of the study drugs. Patients, who have received prior
             radiotherapy to any regional site other than the pelvis, as long as all other
             inclusion criteria are met, could be considered for enrollment after discussion with
             Dr. McCollum.

          -  Is a pregnant or nursing woman

          -  Is unable to comply with requirements of study