Liver Metastases, Colorectal Cancer
Conditions
Keywords
chemoembolization, DC Bead™, Irinotecan, Cetuximab, 5FU/LV, KRAS, metastatic colorectal cancer
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.
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.
Interventions
DEVICEDC Bead™
chemoembolization with DC Bead™ loaded with Irinotecan
DRUGCetuximab
400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
DRUG5 FU
every 2 weeks IV
DRUGIrinotecan
every 4 weeks chemoembolization
Sponsors
Biocompatibles UK Ltd
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of chemoembolization with DC Bead loaded with Irinotecan | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | progression-free survival |
Outcome results
None listed