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Ph II Cabazitaxel DD Liposarcoma

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Disease Information

Descriptive Information
Brief Title † Ph II Cabazitaxel DD Liposarcoma
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 Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Progression free survival (PFS)
Secondary Outcome Measure † Time to progression
Condition † Dedifferentiated Liposarcoma
Intervention † DrugCabazitaxel
Study Arms / Comparison Groups 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. 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 100
Start Date † October 2014
Completion Date February 2019
Primary Completion Date February 2019
Eligibility 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
Gender All
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts †† Ward Sents, +3227741533, ward.sents@eortc.be
Location Countries † Belgium
Administrative Information
NCT ID † NCT01913652
Organization ID EORTC-1202
Secondary IDs †† 2012-003672-39, cabazL06470
Responsible Party Sponsor
Study Sponsor † European Organisation for Research and Treatment of Cancer - EORTC
Collaborators †† Sanofi
Investigators † Principal Investigator: Larry Hayward, MD, Western General Hospital, Edinburgh, United Kingdom
Information Provided By
Verification Date October 2016
First Received Date † July 30, 2013
Last Updated Date April 27, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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