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

Last updated: December 3, 2014
Sponsor: Universitaire Ziekenhuizen Leuven
Overall Status: Trial Not Available

Phase

N/A

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT01631539
2010-018384-42
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, withmetastases predominantly in the liver (≥80% of tumor burden) that are deemedunresectable.

  2. Primary tumour has been treated with complete surgical resection without evidence ofresidual 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 109/L, platelets ≥ 100 x109/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

  1. Women of child bearing potential and fertile men are required to use effectivecontraception (negative βHCG for women of child-bearing age)

  2. Signed, written informed consent

  3. Patients with patent main portal vein

  4. Maximum liver involvement ≤60%

Exclusion

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 exceptadequately treated basal or squamous cell skin cancer or carcinoma in situ of thecervix

  7. Any contraindication for hepatic embolization procedures:

  • porto-systemic shunt

  • hepatofugal blood flow

  • severe atheromatosis

  1. Contraindication to hepatic artery catheterization, such as a patient with severeperipheral vascular disease precluding catheterization

  2. Other significant medical or surgical condition, or any medication or treatmentregimens, that would place the patient at undue risk, that would preclude the safe useof chemoembolization or would interfere with study participation

Study Design

Study Start date:
September 01, 2012
Estimated Completion Date:
December 31, 2014

Study 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.