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

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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Device: DC Bead™; Drug: Cetuximab; Drug: 5 FU; Drug: 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Chemoembolization; chemoembolization with DC Bead™ loaded with Irinotecan	Device: DC Bead™; chemoembolization with DC Bead™ loaded with Irinotecan; Other Names: Irinotecan; Drug: Cetuximab; 400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly; Other Names: Erbitux; Drug: 5 FU; every 2 weeks IV; Other Names: 5 fluoro uracyl; Drug: Irinotecan; every 4 weeks chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of chemoembolization with DC Bead loaded with Irinotecan	Feasibility of the study by measuring the number of enrolled patients who can finish the first cycle of treatment	after one cycle = after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	progression-free survival	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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Biocompatibles UK Ltd
• Investigators: Principal Investigator: Eric Van Cutsem, MD PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: metastatic colorectal cancer; Cetuximab; chemoembolization; Irinotecan; KRAS; DC Bead™; 5FU/LV
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Topoisomerase I Inhibitors; Irinotecan; Cetuximab
• Other Study ID Numbers: 2010-018384-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No