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

NCT01631539 | Withdrawn

• 1 other identifier: 2010-018384-42
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Metastases; Colorectal Cancer

Keywords

chemoembolization; DC Bead™; Irinotecan; Cetuximab; 5FU/LV; KRAS; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Chemoembolization

OTHER

chemoembolization with DC Bead™ loaded with Irinotecan

Device: DC Bead™; Drug: Cetuximab; Drug: 5 FU; Drug: Irinotecan

Interventions

DC Bead™ DEVICE

chemoembolization with DC Bead™ loaded with Irinotecan

Also known as: Irinotecan

Chemoembolization

Cetuximab DRUG

400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly

Also known as: Erbitux

Chemoembolization

5 FU DRUG

every 2 weeks IV

Also known as: 5 fluoro uracyl

Chemoembolization

Irinotecan DRUG

every 4 weeks chemoembolization

Chemoembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
• Primary tumour has been treated with complete surgical resection without evidence of residual tumour
• Patients must have at least 1 measurable lesion (RECIST criteria)
• Performance status ECOG 0-1
• Aged ≥18 years
• Life expectancy \> 3 months
• No prior chemotherapy for metastatic disease
• Hematologic function: WBC ≥ 3.0 x 10\*9/L, platelets ≥ 100 x10\*9/L
• 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
• Women of child bearing potential and fertile men are required to use effective contraception (negative βHCG for women of child-bearing age)
• Signed, written informed consent
• Patients with patent main portal vein

You may not qualify if:

• Presence of CNS metastases
• Contraindications to FU/LV, Irinotecan or Cetuximab
• Active bacterial, viral or fungal infection within 72 hours of study entry
• Women who are pregnant or breast feeding
• Allergy to contrast media or history of severe hypersensitivity to study drugs.
• 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
• Any contraindication for hepatic embolization procedures:
• porto-systemic shunt
• hepatofugal blood flow
• severe atheromatosis
• Contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Biocompatibles UK Ltd: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Eric Van Cutsem, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD PhD Eric Van Cutsem

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: June 29, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12