Overview

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

Status:
Withdrawn

Trial end date:
2014-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Universitaire Ziekenhuizen Leuven

Collaborator:

Biocompatibles UK Ltd

Treatments:

Camptothecin
Cetuximab
Irinotecan

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