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Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC

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: NCT01631539
Recruitment Status : Withdrawn (No patients enrolled)
First Posted : June 29, 2012
Last Update Posted : December 4, 2014
Biocompatibles UK Ltd
Information provided by (Responsible Party):
Prof. Dr. Eric Van Cutsem, Universitaire Ziekenhuizen Leuven

Brief Summary:
The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.

Condition or disease Intervention/treatment Phase
Liver Metastases Colorectal Cancer Device: DC Bead™ Drug: Cetuximab Drug: 5 FU Drug: Irinotecan Not Applicable

Detailed Description:

20 patients will be included. The duration of the trial will be approximately 24 months.

Every 8 weeks there will be a tumour lesion assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemoembolisation With Irinotecan Loaded DC Bead (DEBIRI) in Combination With Cetuximab and 5FU/LV in the First Line Treatment of Patients With KRAS Wildtype Metastatic Colorectal Cancer (mCRC)
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
chemoembolization with DC Bead™ loaded with Irinotecan
Device: DC Bead™
chemoembolization with DC Bead™ loaded with Irinotecan
Other Name: Irinotecan

Drug: Cetuximab
400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
Other Name: Erbitux

Drug: 5 FU
every 2 weeks IV
Other Name: 5 fluoro uracyl

Drug: Irinotecan
every 4 weeks chemoembolization

Primary Outcome Measures :
  1. Feasibility of chemoembolization with DC Bead loaded with Irinotecan [ Time Frame: after one cycle = after 8 weeks ]
    Feasibility of the study by measuring the number of enrolled patients who can finish the first cycle of treatment

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months ]
    progression-free survival

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.

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

Inclusion Criteria:

  1. Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
  2. Primary tumour has been treated with complete surgical resection without evidence of residual tumour
  3. Patients must have at least 1 measurable lesion (RECIST criteria)
  4. Performance status ECOG 0-1
  5. Aged ≥18 years
  6. Life expectancy > 3 months
  7. No prior chemotherapy for metastatic disease
  8. Hematologic function: WBC ≥ 3.0 x 10*9/L, platelets ≥ 100 x10*9/L
  9. Adequate organ function as measured by:

    • Serum creatinine £ 1.5 x upper limit of normal (ULN)
    • Serum transaminases (AST & ALT) £ 5 x ULN
    • Bilirubin> 1.5 times the upper limit of the normal range
  10. Women of child bearing potential and fertile men are required to use effective contraception (negative βHCG for women of child-bearing age)
  11. Signed, written informed consent
  12. Patients with patent main portal vein
  13. Maximum liver involvement ≤60%

Exclusion Criteria:

  1. Presence of CNS metastases
  2. Contraindications to FU/LV, Irinotecan or Cetuximab
  3. Active bacterial, viral or fungal infection within 72 hours of study entry
  4. Women who are pregnant or breast feeding
  5. Allergy to contrast media or history of severe hypersensitivity to study drugs.
  6. Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
  7. Any contraindication for hepatic embolization procedures:

    • porto-systemic shunt
    • hepatofugal blood flow
    • severe atheromatosis
  8. Contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
  9. Other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation

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): NCT01631539

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Biocompatibles UK Ltd
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Principal Investigator: Eric Van Cutsem, MD PhD Universitaire Ziekenhuizen Leuven
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Responsible Party: Prof. Dr. Eric Van Cutsem, Professor MD PhD Eric Van Cutsem, Universitaire Ziekenhuizen Leuven Identifier: NCT01631539    
Other Study ID Numbers: 2010-018384-42
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Prof. Dr. Eric Van Cutsem, Universitaire Ziekenhuizen Leuven:
DC Bead™
metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological