Phase II trial of cabazitaxel in metastatic or inoperable locally advanced dedifferentiated liposarcoma

European Organisation for Research and Treatment of Cancer (EORTC)0 sites50 target enrollmentFebruary 26, 2014

Overview

No summary available.

Registry

who.int

Start Date

February 26, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

European Organisation for Research and Treatment of Cancer (EORTC)

•Registration step 1:
•\- Local diagnosis of DD liposarcoma
•\-Mandatory availability for shipment of formalin\-fixed, paraffin embedded, tumor\-containing tissue blocks from primary tumor and/or metastatic site.
•\-If a block cannot be provided, the following should be submitted:
•? For cases that will be reviewed in UK : 4 x 1 micron sections on coated slides, one thin H\&E stained section and 20 unstained sections of usual thickness (2\-4 micron) on coated slides.
•? For cases that will be reviewed in France: 3 x 4 micron sections on unstained (coated) slides for FISH and 15 unstained slides (4 micron) for immunohistochemistry.
•\-Before patient registration step 1, written informed consent for central collection of tissue block or slides and any other trial\-specific procedures must be obtained from the patient according to ICH/GCP, and national/local regulations, allowing for collection, storage and analysis of tissue and screening procedures.
•Registration step 2:
•\-Central pathology confirmation of DD liposarcoma within 3 weeks after registration step 1\.
•\-Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months prior to registration step 2\.

•Registration step 2
•\-inflammation of the urinary bladder (cystitis)
•\-symptomatic CNS metastases
•\-invasive malignancy within 5 years, with the exception of non\-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma
•\-significant cardiac disease: i.e. active ischaemic heart disease or cardiac failure
•\-uncontrolled severe illness or medical condition (including acute infection, uncontrolled diabetes), other than the DD liposarcoma
•\-concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash\-out period is necessary for patients who are already on these treatments)
•\-known hypersensitivity to taxanes or their excipients (cabazitaxel, like docetaxel, is solubilized in polysorbate 80 and ethanol)
•\-any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before registration in the trial.