Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

NCT03514381 | Completed Phase 4

• 1 other identifier: 17 SARC 04
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Soft Tissue Sarcoma

Keywords

Soft Tissue Sarcoma; Ifosfamide; Aprepitant; Doxorubicin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

  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

Study Arms (1)

Patients starting a treatment with Doxorubicin and Ifosfamide

OTHER

Drug: Patients starting a treatment with Doxorubicin and Ifosfamide

Interventions

Patients starting a treatment with Doxorubicin and Ifosfamide DRUG

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)

Patients starting a treatment with Doxorubicin and Ifosfamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hemoglobin \> 9.0 g/dL, Neutrophils \> 1500/mm3, Platelets \> 100000/mm3
• Creatinine clearance (MDRD formula) \> 60ml/min.
• AST/ALT \< 2.5 x ULN (5 x ULN in patients with hepatic metastasis).
• 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.

You may not qualify if:

• Previous treatment with Ifosfamide.
• Patient who has already started doxorubicin and ifosfamide treatment.
• Any medical condition that can increase the patient's risk
• Active infection
• Active hepatitis or cirrhosis
• Recipients of organ transplants or immunocompromised patients, including Human Immunodeficiency Virus (HIV) infection
• 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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (3)

Institut Bergonie

Bordeaux, 33076, France

Location

Institut Regional Du Cancer de Montpellier (Icm)

Montpellier, 34298, France

Location

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 36882147 RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

Doxorubicin; Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: May 18, 2018
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (3)