DEBDOX for liver metastases in breast carcinoma

• Conditions: Patients with breast carcinoma and liver-dominant metastasis; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000973-22-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-13
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•Patients with biopsy proven liver dominant ( over 50% volume) metastasis of breast carcinoma

•Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria)

•Hematologic function: ANC ? 1.5 x 109/L, platelets ? 75 x109/L, INR <1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to intervention

•Adequate liver function as measured by: Total bilirubin = 2.0 mg/dl

•Adequate renal function (creatinine = 2.3 mg/dl)
•written informed consent
•over 18 years of age
•eligible for treatment
• non pregnant
• using an acceptable contraceptive if premenopausal.

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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•contraindication to angiographic and selective visceral catheterization
•significant extrahepatic disease representing an eminent life-threatening outcome : more than 75% of hepatic parenchymal involvement
• severe liver dysfunction
• and severe cardiac comorbidities.
•Active bacterial, viral or fungal infection within 72 hours of study entry

•Women who are pregnant or breast feeding

?ECOG Performance Status score of >3

?Life expectancy of < 3 months

•Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated

•Any contraindication for hepatic embolization procedures:
-Large shunt as determined by the investigator (pretesting with TcMMA not required)
-Severe atheromatosis vascular disease that precludes arterial cannulization
-Hepatofugal blood flow
-Main portal vein occlusion (e.g. thrombus or tumor)

•Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation

•Patients with prior contraindications for the use of doxorubicin

Study & Design

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