Regional Chemotherapy with Intrahepatic Irinotecan Beads for patients with Livermetastatic Colorectal Cancer.

Phase 1

• Conditions: Metastatic colorectal cancer with metastasis confined to the liver; MedDRA version: 14.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000987-11-DK
• Lead Sponsor: Anni Ravnbek Jensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-31
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

-Informed consent
-Age over 18 years
-Performance status 0-1 and remaining life expectancy of> 3 months
-Histologically proven adenocarcinoma from the colon or rectum
-Either remove the primary tumor or primary tumor is deemed operable
-Liver metastases where local treatment is not possible
-The presence of liver metastases documented by contrast multiphase CT
-Extrahepatic disease not detected
-No chemo therapy for at least 6 months (adjuvant)
-Liver involvement <50%
-Neutrophils> 1.5 x 109 and platelets> 100 x 109, bilirubin <2.0 x ULN, INR <1.5
-Creatinine clearance calculated by Cockcroft-Gault> 40 ml / min
-INR <1.5
-It is possible to implement DEBIRI-TACE

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

-Second malignancy except basal cell carcinoma and in situ carcinoma of the cervics uteri
-Treatment with other experimental drugs or participation in other trials.
-Pre-existing polyneuropathy more than Grade 1 (NCI CTC v. 3)
-Other serious medical disease, cardiomyopathy> NYHA II, AMI where aggretions antiplatelet therapy is ongoing. Symptoms of angina pectoris.
-Arterial thromboembolic events including transient ischemic attack, or myocardial infarction within 12 months.
-Congenital bleeding diathesis or acquired coagulopathy
-BMI> 40
-Treatment with St. John's Wort, CYP3A-inducing anticonvulsants or ketoconazole.
-Physical or mental illness that would prevent understanding or Compliance
-Patients with uncontrolled infection
-Pregnant or lactating women. In fertile women, this is done with a negative pregnancy test
-Women of childbearing potential not using adequate contraception
-Patients of linguistic, intellectual or cultural reasons do not fully understand the treatment concept and respond appropriately to complications and side effects
-Sensitivity, to any or several of the known active agents, or adjuvants which form part of the intended treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified