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A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum

Phase 2
18 Years
Open (Enrolling)
Rectal Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum

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

- 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

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

- 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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to determine the pathologic response rate, using tumor regression grading, to treatment with preoperative chemoradiotherapy (pelvic radiotherapy with concurrent 5-FU) with and without concurrent ERBITUX.

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator

Andrew D McCollum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

February 2007

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms



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