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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
Prof. Dr. Eric Van Cutsem, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01631539
First received: September 14, 2011
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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 Intervention
Liver Metastases
Colorectal Cancer
Device: DC Bead™
Drug: Cetuximab
Drug: 5 FU
Drug: Irinotecan

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    progression-free survival


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Chemoembolization
chemoembolization with DC Bead™ loaded with Irinotecan
Device: DC Bead™
chemoembolization with DC Bead™ loaded with Irinotecan
Other Names:
  • DC Bead™
  • 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
Other Name: Irinotecan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631539

Contacts
Contact: Eric Van Cutsem, MD PhD +3216344225 eric.vancutsem@uzleuven.be
Contact: Geert Maleux, MD PhD +3216340751 geert.maleux@uzleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Biocompatibles UK Ltd
Investigators
Principal Investigator: Eric Van Cutsem, MD PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Prof. Dr. Eric Van Cutsem, Professor MD PhD Eric Van Cutsem, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01631539     History of Changes
Other Study ID Numbers: 2010-018384-42
Study First Received: September 14, 2011
Last Updated: June 27, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
chemoembolization
DC Bead™
Irinotecan
Cetuximab
5FU/LV
KRAS
metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Fluorouracil
Irinotecan
Cetuximab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 23, 2014