Ph II Cabazitaxel/Ifosfamide DD Liposarcoma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by European Organisation for Research and Treatment of Cancer - EORTC
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: NA
Last verified: July 2013
History: No changes posted
  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: February 2014
Estimated Primary Completion Date: February 2016 (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
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

Contacts
Contact: Angelique Deleersnijder, PhD +32 2 7741035 angelique.deleersnijder@eortc.be
Contact: Vinciane Vinckx +32 2 7741032 vinciane.vinckx@eortc.be

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

No publications provided

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: July 30, 2013
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014