Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC
NCT ID: NCT01631539
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-09-30
2014-12-31
Brief Summary
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Detailed Description
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Every 8 weeks there will be a tumour lesion assessment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemoembolization
chemoembolization with DC Bead™ loaded with Irinotecan
DC Bead™
chemoembolization with DC Bead™ loaded with Irinotecan
Cetuximab
400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
5 FU
every 2 weeks IV
Irinotecan
every 4 weeks chemoembolization
Interventions
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DC Bead™
chemoembolization with DC Bead™ loaded with Irinotecan
Cetuximab
400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
5 FU
every 2 weeks IV
Irinotecan
every 4 weeks chemoembolization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Biocompatibles UK Ltd
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Prof. Dr. Eric Van Cutsem
Professor MD PhD Eric Van Cutsem
Principal Investigators
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Eric Van Cutsem, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Other Identifiers
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2010-018384-42
Identifier Type: -
Identifier Source: org_study_id