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A Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of the Rectum

Phase 2
18 Years
Not Enrolling
Rectal Cancer

Thank you

Trial Information

A Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of the Rectum

Primary Objective:

- Down-staging of the tumor

Secondary Objectives:

- Pathologic response rate

- Tumor marker response

- Incidence of sphincter sparing surgery

- Progression-free survival

- Overall Survival

Inclusion Criteria:

- All patients must have newly diagnosed, histologically proven adenocarcinoma of the
rectum. Locally advanced T3, T4 or any T with N1, N2, staged by trans-rectal

- All patients must have an abdominal/pelvis CT scan or MRI confirming no evidence of
distant metastases.

- Patients must have an ECOG PS ≤ 2

- Patient has signed informed consent

- Lower Age Limit: 18 years

- Upper Age Limit: No upper age limit

- Laboratory parameters:

- Hgb: > 9.0 g/dl

- ANC >1500/ul

- Platelet >100,000/ul

- Creatinine < 2x ULN

- Bilirubin < 2x ULN

- ALT < 2x ULN

Exclusion Criteria:

- Administration of any prior systemic anticancer therapy for colorectal cancer (eg,
chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy,
cytokine therapy, angiogenesis inhibitors).

- Previous intra-arterial cytotoxic chemotherapy given as treatment for colorectal

- Previous pelvic radiotherapy.

- Known allergy or intolerance to oxaliplatin, 5-FU, cetuximab or leucovorin.

- Pregnant or breast-feeding women: female patients must agree to use effective
contraception, must be surgically sterile, or must be postmenopausal. Male patients
must agree to use effective contraception or be surgically sterile. The definition
of effective contraception will be based on the judgment of the principal
investigator or a designated associate. All at-risk female patients must have a
negative serum pregnancy test within 7 days prior to registration.

- Active inflammatory bowel disease, significant bowel obstruction, or chronic diarrhea
(grade 2).

- Myocardial infarction or stroke within the previous 6 months, or ongoing unstable
angina, symptomatic congestive heart failure, or serious uncontrolled cardiac

- Known human immunodeficiency virus (HIV) positivity or
acquired-immunodeficiency-syndrome (AIDS)-related illness.

- No previous or concurrent malignancy is allowed except for adequately treated basal
cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which
the patient has been disease-free for 3 years.

- Known CNS metastases

- Preexisting neuropathy > Grade 2

- Prior therapy which specifically and directly targets the EGFR pathway

- Prior severe infusion reaction to a monoclonal antibody

- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure and cardiomyopathy with decreased ejection fraction.

Type of Study:


Study Design:

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

Outcome Measure:

response to therapy

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Michael Huie, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

UW Paul P. Carbone Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

2007-0197 (CO06207)



Start Date:

December 2007

Completion Date:

November 2009

Related Keywords:

  • Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms



University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164