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Ph II Cabazitaxel DD Liposarcoma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913652
Recruitment Status : Active, not recruiting
First Posted : August 1, 2013
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dedifferentiated Liposarcoma Drug: Cabazitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

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 Name: Jevtana




Primary Outcome Measures :
  1. 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 :
  1. Time to progression [ Time Frame: 3 years from first patient in ]
  2. Progression free survival [ Time Frame: 3 years from first patient in ]
  3. Overall survival [ Time Frame: 3 years from first patient in ]
  4. Objective tumor response [ Time Frame: 3 years from first patient in ]
    Objective tumor response as defined by RECIST 1.1

  5. 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

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

  7. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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


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

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01913652    
Other Study ID Numbers: EORTC-1202
2012-003672-39 ( EudraCT Number )
cabazL06470 ( Other Identifier: Sanofi )
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
dedifferentiated liposarcoma
cabazitaxel
Additional relevant MeSH terms:
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Liposarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma