EORTC-1202-STBSG
Research type
Research Study
Full title
Randomized phase II trial of cabazitaxel or prolonged infusional ifosfamide in metastatic or inoperable locally advanced dedifferentiated liposarcoma
IRAS ID
149992
Contact name
Larry Hayward
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2012-003672-39
Clinicaltrials.gov Identifier
Research summary
Summary of Research
Soft tissue sarcomas comprise a heterogeneous group of more than 50 different types of cancer with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. Survival and response rates to chemotherapy vary amongst subtypes but, until recently, treatment approaches have generally treated soft tissue sarcomas as a single group. There is a need to differentiate more between the many subtypes and to improve treatment options through clinical trials tailored towards individual subtypes.
The main objective of this trial is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient antitumor activity (as measured by progression free survival at 12 weeks) in patients with metastatic or inoperable locally advanced dedifferentiated (DD) liposarcoma to justify further investigation of the efficacy of these treatment options in a phase III setting.
This trial will be an international, multi-center, open label phase II trial where patients with metastatic or inoperable locally advanced DD liposarcoma will be randomized between two parallel treatment arms - cabazitaxel or prolonged infusional ifosfamide.
The primary endpoint of the study is progression free survival at 12 weeks after randomisation and the secondary endpoints include time to progression, progression free survival, overall survival, objective tumor response, time to onset of response, duration of response, and safety.
Each treatment arm will be independently assessed against a benchmark previously established by prior research of the EORTC soft tissue and bone sarcoma group. This benchmark, measured in terms of progression free survival at 12 weeks, is useful in indicating whether or not a treatment has sufficient effect to merit further investigation as part of a future larger randomised controlled phase III clinical trial.Summary of Results
This trial looked at cabazitaxel for liposarcoma that had spread to other parts of the body or it wasn’t possible to remove it with surgery. This is advanced liposarcoma. The trial was open for people to join between 2017 and 2019.Liposarcoma is a type of soft tissue sarcoma. Doctors often treat liposarcoma with chemotherapy. When this trial was done, they may have used drugs such as doxorubicin and ifosfamide. But sometimes they didn’t work very well. So, doctors wanted to improve treatment.
In this trial they looked at a chemotherapy drug called cabazitaxel.
The main aims of the trial were to find out:
if cabazitaxel can stop advanced liposarcoma from getting worse
more about the side effects
Trial design
This was a phase 2 trial. It took place worldwide. 38 people were suitable to have treatment as part of this trial. Everyone taking part had cabazitaxel. They had it for as long as it was working and for as long as the side effects weren’t too bad.
Results
After about 12 weeks, the team looked at the number of people living whose cancer hadn’t started to grow again. They found this was 21 out of 38 people (55%).
They also looked at how well treatment worked. They found the cancer:
went away completely in one person
shrunk a bit in 2 people
stayed the same in 23 people
got worse in 12 people
The team followed everyone up for about 22 months They looked at how long it was before the cancer started to grow again. Half the people’s cancer got worse 6 months after joining the trial. They also looked at how long people lived. Half the people were living 21 months after joining the trial.
These results are similar to having standard chemotherapy available when the trial was done. However, note that further research that compares Cabazitaxel to standard chemotherapy is needed to confirm the results
Side effects
The trial team looked at the severe side effects of cabazitaxel. The most common included:
an increased risk of infection
a temperature and a drop in a type of white blood cell called neutrophils
an increased risk of tiredness and breathlessness
No patient died from side effects related to the drug.
Detailed results have been published on the EUDRACT website ( EUDRACT #: 2012-003672-39).
Conclusion
The trial team concluded that the results from this small trial are encouraging. Cabazitaxel worked for some people with advanced liposarcoma to at least temporarily slow the growth. These findings suggest that it should be looked at in a larger phase 3 trial. This is to see how well it works when compared to standard chemotherapy for liposarcoma
REC name
Scotland B REC
REC reference
14/SS/0095
Date of REC Opinion
29 Jul 2014
REC opinion
Further Information Favourable Opinion