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

Colorectal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01631539
• Other study ID #: 2010-018384-42
• Status: Withdrawn
• Phase: N/A
• First received: September 14, 2011
• Last updated: December 3, 2014
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ßHCG 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases

Intervention

Device:
• DC Bead™
chemoembolization with DC Bead™ loaded with Irinotecan

Drug:
• Cetuximab
400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
• 5 FU
every 2 weeks IV
• Irinotecan
every 4 weeks chemoembolization

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Biocompatibles UK Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No