This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant. The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre. Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
9 blood samples will be collected at each Cycle: * Cycle 1 (Day 1-Day 2-Day 3) * Cycle 2 (Day 1-Day 2-Day 3)
Institut Bergonie
Bordeaux, France
Institut Regional Du Cancer de Montpellier (Icm)
Montpellier, France
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, France
Evolution of 2d-Ifo plasma concentrations between the 1st cycle (without co-exposure to the Aprepitant) and the 2nd cycle (with co-exposure to the Aprepitant)
Time frame: Cycle 2 Day 3 for each patient
Toxicity assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Time frame: Cycle 3 Day 1 for each patient
Evolution of plasma concentrations of ifosfamide and its serum metabolites between the first and second cycles
Time frame: Cycle 3 Day 1 for each patient
The rate of objective responses determined according to the criteria RECIST v 1.1
Time frame: Cycle 3 Day 1 for each patient
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