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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients starting a treatment with Doxorubicin and Ifosfamide | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients starting a treatment with Doxorubicin and Ifosfamide | Drug | 9 blood samples will be collected at each Cycle:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Cycle 2 Day 3 for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 | Cycle 3 Day 1 for each patient | |
| Evolution of plasma concentrations of ifosfamide and its serum metabolites between the first and second cycles |
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Inclusion Criteria:
Age ≥ 18 years.
Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or metastatic).
Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative treatment).
Screening laboratory values must meet the following criteria:
Evaluable disease (measurable per RECIST or not), if applicable.
Patient must provide written informed consent prior to any study specific procedures.
Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria:
Previous treatment with Ifosfamide.
Patient who has already started doxorubicin and ifosfamide treatment.
Any medical condition that can increase the patient's risk
Pregnant or breastfeeding women
Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
Patient protected by law
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33076 | France | |||
| Institut Regional Du Cancer de Montpellier (Icm) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36882147 | Result | Valentin T, Lambert M, Chaltiel L, Allal B, Mseddi M, Yakoubi M, Chevreau C, Toulmonde M, Firmin N, Filleron T, Chatelut E. Population pharmacokinetic analysis reveals no impact of aprepitant on the pharmacokinetics of ifosfamide, 2-dechloroifosfamide, and 3-dechloroifosfamide. Eur J Pharm Sci. 2023 Jun 1;185:106420. doi: 10.1016/j.ejps.2023.106420. Epub 2023 Mar 5. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D007069 | Ifosfamide |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Cycle 3 Day 1 for each patient |
| The rate of objective responses determined according to the criteria RECIST v 1.1 | Cycle 3 Day 1 for each patient |
| Montpellier |
| 34298 |
| France |
| Institut Universitaire Du Cancer de Toulouse - Oncopole | Toulouse | 31059 | France |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |