Epirubicin to patients with colorectal cancer

Conditions: TOP2A gene amplified and oxaliplatin refractory metastatic colorectal cancer
MedDRA version: 14.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-001648-79-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 25

Inclusion Criteria

• Histologically verified CRC with non-resectable mCRC
• Oxaliplatin resistant disease i.e. progression during or after oxaliplatin-based therapy
• Available FFPE tumor tissue blocks and TOP2A/CEN-17 ratio = 1.5 in their malignant tumor cells in the primary tumor biopsy or in a biopsy from a metastatic lesion
• Measurable or non-measurable disease
• Age = 18 years
• Performance status (WHO) of 0-2 and a life expectancy of at least 3 months
• Adequate haematological function defined as ANC = 1.5 x 109/l and platelets = 100 x 109/l
• Adequate liver function defined as bilirubin = 1,5 x UNL (upper normal limit)
• Written informed consent
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 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

• Previous or synchronous malignancy, with the exception of adequately treated basal cell skin cancer or cervical cancer in situ
• Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives
• Pregnant or lactating women (in fertile women this is ensured according to guidelines of Danish Health and Medicines Authority)
• Known hypersensitivity to epirubicin
• Known heart disease
• Prior treatment of mCRC with a topoisomerase inhibitor e.g. irinotecan

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Progression-free survival;Secondary Objective: Overall survival<br>Response rate<br>Toxicity<br>Validation of plasma TIMP-1 and immunhistochemical TIMP-1 as biomarkers for anthracycline sensitivity/resistance<br>study the relationship between TOP2A and TOP1 gene amplifications;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: Overall survival<br>

Secondary Outcome Measures