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Ph II Cabazitaxel DD Liposarcoma

This study is currently recruiting participants.
Verified October 2016 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
ClinicalTrials.gov Identifier:
NCT01913652
First Posted: August 1, 2013
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  Purpose
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 or prolonged infusional ifosfamide demonstrate sufficient antitumor activity for liposarcoma.

Condition Intervention Phase
Dedifferentiated Liposarcoma Drug: Cabazitaxel Drug: Prolonged infusional ifosfamide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Time to progression [ Time Frame: 3 years from first patient in ]
  • Progression free survival [ Time Frame: 3 years from first patient in ]
  • Overall survival [ Time Frame: 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

  • 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

  • Duration of response [ Time Frame: 3 years from first patient in ]
    Duration of response will be measured for patients achieving an objective response

  • 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.


Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Jevtana
Experimental: Prolonged infusional ifosfamide
Ifosfamide will be administered at a dose of 1 g/m²/day, along with mesna at 550 mg/m²/day, both as a prolonged intravenous continuous infusion via a central venous catheter and an appropriate ambulatory infusional pump (per local institutional policies) for days 1 to 14 of each 28 day cycle.Treatment will be administered until disease progression, unacceptable toxicity or patient's refusal.
Drug: Prolonged infusional ifosfamide

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Local diagnosis of dedifferentiated liposarcoma
  • Age 18-70 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 organ functions
  • Birth control measures
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913652


Contacts
Contact: Ward Sents +3227741533 ward.sents@eortc.be
Contact: Vinciane Vinckx +32 2 7741032 vinciane.vinckx@eortc.be

Locations
Belgium
Universitair Ziekenhuis Antwerpen (117) Recruiting
Antwerpen, Belgium
Contact: Jan Van Den Brande       jan.van.den.brande@uza.be   
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101) Recruiting
Brussels, Belgium
Contact: Thierry Gil       thierry.gil@bordet.be   
France
Centre Leon Berard (227) Recruiting
Lyon, France
Contact: Jean-yves Blay       jean-yves.blay@lyon.unicancer.fr   
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287) Recruiting
Marseille, France
Contact: Florence Duffaud       florence.duffaud@mail.ap-hm.fr   
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori (704) Recruiting
Milano, Italy
Contact: Paolo Casali       Paolo.Casali@istitutotumori.mi.it   
Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908) Recruiting
Padova, Italy
Contact: Umberto Basso       u.basso@tin.it   
United Kingdom
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659) Recruiting
Bebington, United Kingdom
Contact: Nasim Ali       nasim.ali@clatterbridgecc.nhs.uk   
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Paul Ramage    0131 537 2916    paul.ramage@rmh.nhs.uk   
Contact: Jennifer Waddell    0131 537 2444    jennifer.waddell@rmh.nhs.uk   
Principal Investigator: Larry Hayward         
Royal Marsden Hospital - Chelsea, London (613) Recruiting
London, United Kingdom
Contact: Charlotte Benson       charlotte.benson@rmh.nhs.uk   
The Christie NHS Foundation Trust (610) Recruiting
Manchester, United Kingdom
Contact: Michael Leahy       Michael.Leahy@christie.nhs.uk   
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Sanofi
Investigators
Principal Investigator: Larry Hayward, MD Western General Hospital, Edinburgh, United Kingdom
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01913652     History of Changes
Other Study ID Numbers: EORTC-1202
2012-003672-39 ( EudraCT Number )
cabazL06470 ( Other Identifier: Sanofi )
First Submitted: July 30, 2013
First Posted: August 1, 2013
Last Update Posted: April 28, 2017
Last Verified: October 2016

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
dedifferentiated liposarcoma
cabazitaxel
ifosfamide

Additional relevant MeSH terms:
Liposarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents