Ph II Cabazitaxel DD Liposarcoma
Primary Purpose
Dedifferentiated Liposarcoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cabazitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Dedifferentiated Liposarcoma focused on measuring dedifferentiated liposarcoma, cabazitaxel
Eligibility 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
Sites / Locations
- Universitair Ziekenhuis Antwerpen (117)
- Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
- CHU de Dijon - Centre Georges-Francois-Leclerc (229)
- Centre Leon Berard (227)
- Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)
- Fondazione IRCCS Istituto Nazionale dei Tumori (704)
- Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)
- Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)
- Western General Hospital
- Royal Marsden Hospital - Chelsea, London (613)
- The Christie NHS Foundation Trust (610)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cabazitaxel
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment
Secondary Outcome Measures
Time to progression
Progression free survival
Overall survival
Objective tumor response
Objective tumor response as defined by RECIST 1.1
Time to onset of response
Time to onset of response will be measured for patients achieving an objective response
Duration of response
Duration of response will be measured for patients achieving an objective response
Occurence of adverse events
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
Full Information
NCT ID
NCT01913652
First Posted
July 30, 2013
Last Updated
September 10, 2021
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01913652
Brief Title
Ph II Cabazitaxel DD Liposarcoma
Official Title
Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dedifferentiated Liposarcoma
Keywords
dedifferentiated liposarcoma, cabazitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabazitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cabazitaxel
Other Intervention Name(s)
Jevtana
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment
Time Frame
3 years from first patient in
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
3 years from first patient in
Title
Progression free survival
Time Frame
3 years from first patient in
Title
Overall survival
Time Frame
3 years from first patient in
Title
Objective tumor response
Description
Objective tumor response as defined by RECIST 1.1
Time Frame
3 years from first patient in
Title
Time to onset of response
Description
Time to onset of response will be measured for patients achieving an objective response
Time Frame
3 years from first patient in
Title
Duration of response
Description
Duration of response will be measured for patients achieving an objective response
Time Frame
3 years from first patient in
Title
Occurence of adverse events
Description
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
Time Frame
3 years from first patient in
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Hayward, MD
Organizational Affiliation
Western General Hospital, Edinburgh, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen (117)
City
Antwerpen
Country
Belgium
Facility Name
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
City
Brussels
Country
Belgium
Facility Name
CHU de Dijon - Centre Georges-Francois-Leclerc (229)
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Leon Berard (227)
City
Lyon
Country
France
Facility Name
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)
City
Marseille
Country
France
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori (704)
City
Milano
Country
Italy
Facility Name
Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)
City
Padova
Country
Italy
Facility Name
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)
City
Bebington
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Chelsea, London (613)
City
London
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust (610)
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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Ph II Cabazitaxel DD Liposarcoma
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