Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (\> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Universitair Ziekenhuis Antwerpen (117)
Antwerp, Belgium
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
Brussels, Belgium
CHU de Dijon - Centre Georges-Francois-Leclerc (229)
Dijon, France
Centre Leon Berard (227)
Lyon, France
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)
Marseille, France
Fondazione IRCCS Istituto Nazionale dei Tumori (704)
Milan, Italy
Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)
Padua, Italy
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)
Bebington, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Royal Marsden Hospital - Chelsea, London (613)
London, United Kingdom
...and 1 more locations
Progression free survival (PFS)
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment
Time frame: 3 years from first patient in
Time to progression
Time frame: 3 years from first patient in
Progression free survival
Time frame: 3 years from first patient in
Overall survival
Time frame: 3 years from first patient in
Objective tumor response
Objective tumor response as defined by RECIST 1.1
Time frame: 3 years from first patient in
Time to onset of response
Time to onset of response will be measured for patients achieving an objective response
Time frame: 3 years from first patient in
Duration of response
Duration of response will be measured for patients achieving an objective response
Time frame: 3 years from first patient in
Occurence of adverse events
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
Time frame: 3 years from first patient in
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