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Ph II Cabazitaxel/Ifosfamide DD Liposarcoma

This study has suspended participant recruitment.
(Major amendment - change in design)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01913652
First received: July 30, 2013
Last updated: March 7, 2016
Last verified: March 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Cabazitaxel or Prolonged Infusional Ifosfamide 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 3 years from first patient in ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years from first patient in ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: 3 years from first patient in ] [ Designated as safety issue: No ]
    Objective tumor response as defined by RECIST 1.1

  • Time to onset of response [ Time Frame: 3 years from first patient in ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Duration of response will be measured for patients achieving an objective response

  • Occurence of adverse events [ Time Frame: 3 years from first patient in ] [ Designated as safety issue: Yes ]
    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 Primary Completion Date: February 2017 (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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913652

Locations
Belgium
Universitair Ziekenhuis Antwerpen (117)
Antwerpen, Belgium
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
Brussels, Belgium
France
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
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  cabazL06470 
Study First Received: July 30, 2013
Last Updated: March 7, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 26, 2016