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

Primary Purpose

Liver Metastases, Colorectal Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

DC Bead™

Cetuximab

5 FU

Irinotecan

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring chemoembolization, DC Bead™, Irinotecan, Cetuximab, 5FU/LV, KRAS, metastatic colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Maximum liver involvement ≤60%

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Chemoembolization

Arm Description

chemoembolization with DC Bead™ loaded with Irinotecan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

progression-free survival

Full Information

NCT ID

NCT01631539

First Posted

September 14, 2011

Last Updated

December 3, 2014

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Biocompatibles UK Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01631539

Brief Title

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

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Withdrawn

Why Stopped

No patients enrolled

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Biocompatibles UK Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Metastases, Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemoembolization

Arm Type

Other

Arm Description

chemoembolization with DC Bead™ loaded with Irinotecan

Intervention Type

Device

Intervention Name(s)

DC Bead™

Other Intervention Name(s)

Irinotecan

Intervention Description

chemoembolization with DC Bead™ loaded with Irinotecan

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5 FU

Other Intervention Name(s)

5 fluoro uracyl

Intervention Description

every 2 weeks IV

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

every 4 weeks chemoembolization

Primary Outcome Measure Information:

Title

Feasibility of chemoembolization with DC Bead loaded with Irinotecan

Description

Feasibility of the study by measuring the number of enrolled patients who can finish the first cycle of treatment

Time Frame

after one cycle = after 8 weeks

Secondary Outcome Measure Information:

Title

progression-free survival

Description

progression-free survival

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Maximum liver involvement ≤60% Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Van Cutsem, MD PhD

Organizational Affiliation

Universitaire Ziekenhuizen KU Leuven

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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