COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic FOLFOX6 (DEBIRI)

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: NCT00932438
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : April 18, 2013
Biocompatibles UK Ltd
Information provided by (Responsible Party):
University of Louisville

Brief Summary:
This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.

Condition or disease Intervention/treatment Phase
Colon Cancer With Metastases to the Liver Device: LC bead loaded with Irinotecan Drug: FOLFOX6 and Avastin Phase 1 Phase 2

Detailed Description:
This is a multicentre, open labeled, prospective, randomized, controlled phase I/II study designed to assess the clinical performance of chemoembolization with LC Bead, loaded with irinotecan in combination with intravenous chemotherapy and bevacizumab versus intravenous chemotherapy in combination with bevacizumab in the treatment of unresectable liver metastases in patients with colorectal cancer.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy
Study Start Date : June 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Irinotecan Beads with FOLFOX6 Device: LC bead loaded with Irinotecan
Chemoembolization using LC beads loaded with 100mg Irinotecan in combination with Fluorouracil, Oxaliplatin, Leucovorin and Avastin alternating on a 2 weekly schedule
Other Name: LC Beads, TACE, FOLFOX 6

Active Comparator: FOLFOX6/Avastin alone Drug: FOLFOX6 and Avastin
Fluorouracil, Oxaliplatin, Leucovorin and Avastin given biweekly
Other Name: FOLFOX6, Liver

Primary Outcome Measures :
  1. Tumor Response [ Time Frame: Six weeks post second TACE treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
  • Patients with at least one measurable liver metastases, with size > 1cm (modified RECIST criteria)
  • Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
  • Patients with patent main portal vein
  • ECOG Performance Status score of < 2
  • Life expectancy of > 3 months
  • Non-pregnant with an acceptable contraception in premenopausal women.
  • Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥75 x109/L, INR ≤1.3* (*If patient is on anticoagulants, they must be able to stop medication temporarily prior to TACE and must have INR ≤1.3 prior to receiving TACE) Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl, Adequate Hemoglobin and Hematocrit as measured by (Male: for approximate 45 - 62%; and approximate Female: 37 - 48%) or Hemoglobin (Male: approximate 13 - 18 gm/dL Female: approximate 12 - 16 gm/dL). If patient is asymptomatic with Hemoglobin for male 10 to 12.9 or Female 9.5 to 11.9 and do not wish to be transfused they still will be eligible for treatment.
  • Adequate renal function (creatinine ≤ 2.0mg/dl)
  • Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age)
  • Signed, written informed consent
  • Patient is at least one month out from any treatment for Stage III colorectal cancer
  • Patient is at least one year out from any treatment for their Stage IV colorectal cancer.

    - these patients should not be candidates for curative treatments, and will have recovered from any chemotherapeutic toxicities' they may have experienced."

  • Less than 60% liver tumor replacement


  • "Any patient eligible for curative treatment (i.e. resection or radiofrequency ablation). Note: resectability is defined as a single tumor <5cm with adequate liver function defined: Total bilirubin ≤ 2.0mg/dl" non-resectability includes patients with greater than 6, tumors close to blood vessels, patients with hepatic-pulmonary shunting, or patients of poor performance"
  • Active bacterial, viral or fungal infection within 72 hours of study entry
  • Women who are pregnant or breast feeding
  • Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated.
  • Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous carcinoma of the skin.
  • Any contraindication for hepatic embolization procedures:

    • Large shunt as determined by the investigator (pretesting with TcMMA not required)
    • Severe atheromatosis
    • Hepatofugal blood flow
    • Main portal vein occlusion (e.g. thrombus or tumor)
  • Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation
  • Patients with prior contraindications for the use of irinotecan therapy-this would include chronic inflammatory bowel disease and or bowel obstruction, history of severe hypersensitivity reactions to irinotecan hypochloride, trihydrate, lactic acid or to any of the excipients of Camptostar, severe bone marrow failure, history of Gilbert Syndrome or concomitant use with St. John's Wort
  • Patients with prior contraindications for the use of fluorouracil, oxaliplatin, leucovorin or bevacizumab

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): NCT00932438

Layout table for location information
United States, Alabama
Clearview Cancer Center
Huntsville, Alabama, United States, 35805
United States, California
Radiology Associates of Sacramento/Sutter Cancer Center
Sacramento, California, United States, 95816
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Northside Hospital/GA Cancer Specialists
Atlanta, Georgia, United States, 30342
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Mississippi
Hematology and Oncology Assoc. at Bridgeport
Tupelo, Mississippi, United States, 38801
United States, Missouri
Washington University/Alvin J. Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Oregon
Providence Portland Medical Center/Providence Cancer Center
Portland, Oregon, United States, 97213
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Sponsors and Collaborators
University of Louisville
Biocompatibles UK Ltd
Layout table for investigator information
Study Director: Robert CG Martin, MD, PhD University of Louisville
Additional Information:
Layout table for additonal information
Responsible Party: University of Louisville Identifier: NCT00932438    
Other Study ID Numbers: DEBIRI # 09.0034
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: November 2011
Keywords provided by University of Louisville:
colon cancer
liver metastases
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplasms, Second Primary
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents