Ph II Cabazitaxel DD Liposarcoma

September 10, 2021 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Universitair Ziekenhuis Antwerpen (117)
      • Brussels, Belgium
        • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
  • France
      • Dijon, France, 21079
        • CHU de Dijon - Centre Georges-Francois-Leclerc (229)
      • Lyon, France
        • Centre Leon Berard (227)
      • Marseille, France
        • Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)
  • Italy
      • Milano, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori (704)
      • Padova, Italy
        • Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)
  • United Kingdom
      • Bebington, United Kingdom
        • Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • London, United Kingdom
        • Royal Marsden Hospital - Chelsea, London (613)
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust (610)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Cabazitaxel
Other Names:
  • Jevtana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 3 years from first patient in
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment
3 years from first patient in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 3 years from first patient in
3 years from first patient in
Progression free survival
Time Frame: 3 years from first patient in
3 years from first patient in
Overall survival
Time Frame: 3 years from first patient in
3 years from first patient in
Objective tumor response
Time Frame: 3 years from first patient in
Objective tumor response as defined by RECIST 1.1
3 years from first patient in
Time to onset of response
Time Frame: 3 years from first patient in
Time to onset of response will be measured for patients achieving an objective response
3 years from first patient in
Duration of response
Time Frame: 3 years from first patient in
Duration of response will be measured for patients achieving an objective response
3 years from first patient in
Occurence of adverse events
Time Frame: 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.
3 years from first patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Sanofi

Investigators

  • Principal Investigator: Larry Hayward, MD, Western General Hospital, Edinburgh, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1202
  • 2012-003672-39 (EudraCT Number)
  • cabazL06470 (Other Identifier: Sanofi)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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