Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV 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. Identifier: NCT00392470
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 26, 2006
Last Update Posted : May 25, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: cetuximab Drug: irinotecan hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Phase 1

Detailed Description:



  • Determine the toxicity of irinotecan hydrochloride and cetuximab in patients with stage III or IV rectal cancer undergoing conformal or intensity-modulated radiotherapy.


  • Determine the rate of pathologic response and histological degree of tumor regression in patients treated with this regimen.
  • Determine the complete resection rate (R0) in patients treated with this regimen.
  • Determine the sphincter preservation rate in patients treated with this regimen.
  • Determine the 30-day postoperative complication rate in patients treated with this regimen.
  • Determine the local and distant relapse rate and site of disease failure in patients treated with this regimen.
  • Estimate the predictive value of fludeoxyglucose F 18 positron emission tomography/CT scan for treatment response compared to endoscopic ultrasonography (EUS), CT scan, and MRI in patients treated with this regimen.
  • Determine the late toxicity of this regimen in these patients.
  • Determine the clinical (radiological) tumor response (i.e., MRI, CT scan, EUS) in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of irinotecan hydrochloride.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43 followed by irinotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, and 29. Patients also undergo conformal radiotherapy or intensity-modulated radiotherapy on days 1-5 for 5 weeks. Patients undergo radical surgery 3-4 weeks after completion of neoadjuvant therapy.

Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Primary Purpose: Treatment
Official Title: Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study
Study Start Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Radiological (clinical) tumor response before surgery
  2. Pathologic response rate and histological degree of tumor regression as measured by Mandard TRG score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the rectum

    • T3-4 and/or N+ (stage IIIB, IIIC, or IV disease)
  • Liver or lung metastasis allowed
  • No recurrent disease


  • WHO performance status 0 or 1
  • Hematologic, liver, and renal function normal
  • Considered fit for chemotherapy, radiotherapy, and surgery
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No symptomatic heart disease or myocardial infarction during the past 6 months
  • No chronic inflammatory bowel disease
  • No malignant tumor during the past 5 years except for completely surgically resected carcinoma of the cervix or squamous cell carcinoma of the skin
  • No other concurrent malignant tumor


  • No prior chemotherapy or radiotherapy for rectal cancer
  • No prior radiotherapy to the pelvis

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 identifier (NCT number): NCT00392470

Kantonsspital Aarau Recruiting
Aarau, Switzerland, CH-5000
Contact: Peter Moosmann, MD, PhD    41-62-838-6051   
Institut Ludwig de Recherche sur le Cancer Recruiting
Epalinges, Switzerland, 1066
Contact: Curzio Ruegg, MD    44-412-1692-5853      
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Michael Montemurro, MD    41-21-314-4530      
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Study Chair: Michael Montemurro, MD Centre Hospitalier Universitaire Vaudois Identifier: NCT00392470     History of Changes
Other Study ID Numbers: CDR0000512816
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the rectum
stage III rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action