Ph II Cabazitaxel DD Liposarcoma

Phase 2

Completed

• Conditions: Dedifferentiated Liposarcoma
• Interventions: Drug: Cabazitaxel

• Registration Number: NCT01913652
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Study Start: 2014-10
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabazitaxel	Cabazitaxel	INN: Cabazitaxel Cabazitaxel will be administered at a dose of 25 mg/m² by intravenous infusion, over 1 hour, on day 1 of each 21 day cycle. Treatment should be administered until disease progression, unacceptable toxicity or patient's refusal.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to progression	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 onset of response	3 years from first patient in	Time to onset of response will be measured for patients achieving an objective response
Progression free survival	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
Overall survival	3 years from first patient in
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.

Trial Locations

Locations (11)

Universitair Ziekenhuis Antwerpen (117); 🇧🇪 Antwerpen, Belgium

Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908); 🇮🇹 Padova, Italy

Centre Leon Berard (227); 🇫🇷 Lyon, France

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101); 🇧🇪 Brussels, Belgium

CHU de Dijon - Centre Georges-Francois-Leclerc (229); 🇫🇷 Dijon, France

Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659); 🇬🇧 Bebington, United Kingdom

Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287); 🇫🇷 Marseille, France

Fondazione IRCCS Istituto Nazionale dei Tumori (704); 🇮🇹 Milano, Italy

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Royal Marsden Hospital - Chelsea, London (613); 🇬🇧 London, United Kingdom

The Christie NHS Foundation Trust (610); 🇬🇧 Manchester, United Kingdom