Clinical Trial: Ph II Cabazitaxel DD Liposarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 or prolonged infusional ifosfamide demonstrate sufficient antitumor activity for liposarcoma.

Detailed Summary:
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: July 30, 2013
Date Started: October 2014
Date Completion: February 2019
Last Updated: April 27, 2017
Last Verified: October 2016