TOP2A gene amplified and oxaliplatin refractory metastatic colorectal cancer MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Epirubicin
Product Name: Epirubicin
Product Code: 24782
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Epirubicin
Other descriptive name: EPIRU
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival;Secondary Objective: Overall survival Response rate Toxicity Validation of plasma TIMP-1 and immunhistochemical TIMP-1 as biomarkers for anthracycline sensitivity/resistance 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate ;Timepoint(s) of evaluation of this end point: Toxicity | — |
Countries
Denmark
Contacts
Public ContactLine Schmidt Tarpgaard
Odense University Hospital
Outcome results
None listed