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

• ClinicalTrials.gov Identifier: NCT01631539
• Recruitment Status: Withdrawn
• First Posted: June 29, 2012
• Last Update Posted: December 4, 2014
• Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Biocompatibles UK Ltd
• Information provided by (Responsible Party): Prof. Dr. Eric Van Cutsem, Universitaire Ziekenhuizen Leuven

Study Description

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Chemoembolization; 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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Biocompatibles UK Ltd

Investigators

• Principal Investigator: Eric Van Cutsem, MD PhD; Universitaire Ziekenhuizen Leuven

More Information

• Responsible Party: Prof. Dr. Eric Van Cutsem, Professor MD PhD Eric Van Cutsem, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT01631539
• Other Study ID Numbers: 2010-018384-42
• First Posted: June 29, 2012
• Last Update Posted: December 4, 2014
• Last Verified: December 2014

Keywords provided by Prof. Dr. Eric Van Cutsem, Universitaire Ziekenhuizen Leuven:

chemoembolization; DC Bead™; Irinotecan; Cetuximab; 5FU/LV; KRAS; metastatic colorectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Irinotecan; Cetuximab; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological