Clinical trial NCT01913652: Ph II Cabazitaxel DD Liposarcoma
Official title: Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dedifferentiated Liposarcoma
Keywords: dedifferentiated liposarcoma
cabazitaxel
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Sanofi
First posted: 2013-08-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 3 years from first patient in
Secondary outcomes:
measure: Time to progression
timeFrame: 3 years from first patient in
measure: Progression free survival
timeFrame: 3 years from first patient in
measure: Overall survival
timeFrame: 3 years from first patient in
measure: Objective tumor response
timeFrame: 3 years from first patient in
measure: Time to onset of response
timeFrame: 3 years from first patient in
measure: Duration of response
timeFrame: 3 years from first patient in
measure: Occurence of adverse events
timeFrame: 3 years from first patient in
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (117)
city: Brussels
country: Belgium
facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
city: Dijon
country: France
facility: CHU de Dijon - Centre Georges-Francois-Leclerc (229)
city: Lyon
country: France
facility: Centre Leon Berard (227)
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori (704)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)
city: Bebington
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - Chelsea, London (613)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust (610)
Study officials:
affiliation: Western General Hospital, Edinburgh, United Kingdom
name: Larry Hayward, MD
role: PRINCIPAL_INVESTIGATOR
References: