Clinical trial NCT01631539: Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liver Metastases
Colorectal Cancer
Keywords: chemoembolization
DC Bead™
Irinotecan
Cetuximab
5FU/LV
KRAS
metastatic colorectal cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Biocompatibles UK Ltd
First posted: 2012-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of chemoembolization with DC Bead loaded with Irinotecan
timeFrame: after one cycle = after 8 weeks
Secondary outcomes:
measure: progression-free survival
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Eric Van Cutsem, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: