Dedifferentiated Liposarcoma
Conditions
Keywords
dedifferentiated liposarcoma, cabazitaxel
Brief summary
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.
Interventions
DRUGCabazitaxel
Sponsors
Sanofi
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Local diagnosis of dedifferentiated liposarcoma * Age 18-75 yrs * WHO performance status 0-1 * Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months * Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1. * One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved). * Adequate haematological, renal and hepatic function * Birth control measures * Estimated life expectancy \> 3 months * Related adverse events from previous therapies ≤ Grade 1 * Written informed consent
Exclusion criteria
* More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization. * Symptomatic CNS metastases * Previous encephalopathy of any cause or other significant neurological condition * Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5 * Pregnancy * inflammation of the urinary bladder (cystitis) * Other invasive malignancy within 5 years (exceptions 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 * Uncontrolled severe illness or medical condition, other than DD liposarcoma * Hypersensitivity to taxanes or their excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 3 years from first patient in | The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 3 years from first patient in | — |
| Overall survival | 3 years from first patient in | — |
| Objective tumor response | 3 years from first patient in | Objective tumor response as defined by RECIST 1.1 |
| Time to progression | 3 years from first patient in | — |
| Duration of response | 3 years from first patient in | Duration of response will be measured for patients achieving an objective response |
| Occurence of adverse events | 3 years from first patient in | This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting. |
| Time to onset of response | 3 years from first patient in | Time to onset of response will be measured for patients achieving an objective response |
Countries
Belgium, France, Italy, United Kingdom
Outcome results
None listed