Ph II Cabazitaxel DD Liposarcoma

Dedifferentiated Liposarcoma Clinical Trial

Official title:

Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913652
• Other study ID #: EORTC-1202
• Secondary ID: 2012-003672-39ca
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: December 2020

Study information

• Verified date: September 2021
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dedifferentiated Liposarcoma
• Liposarcoma

Intervention

Drug:
• Cabazitaxel

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen (117)	Antwerpen
Belgium	Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)	Brussels
France	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
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori (704)	Milano
Italy	Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)	Padova
United Kingdom	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	The Christie NHS Foundation Trust (610)	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Sanofi

Countries where clinical trial is conducted

Belgium,  France,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment	3 years from first patient in
Secondary	Time to progression		3 years from first patient in
Secondary	Progression free survival		3 years from first patient in
Secondary	Overall survival		3 years from first patient in
Secondary	Objective tumor response	Objective tumor response as defined by RECIST 1.1	3 years from first patient in
Secondary	Time to onset of response	Time to onset of response will be measured for patients achieving an objective response	3 years from first patient in
Secondary	Duration of response	Duration of response will be measured for patients achieving an objective response	3 years from first patient in
Secondary	Occurence of adverse events	This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.	3 years from first patient in