Skip to main content
OpenTrials
Completed

NCT Number: NCT03514381

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut Bergonie, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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
  • 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

Treatment and study plan

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)

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)

    Time frame: Cycle 2 Day 3 for each patient

Secondary outcomes

  1. 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

  2. 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

  3. The rate of objective responses determined according to the criteria RECIST v 1.1

    Time frame: Cycle 3 Day 1 for each patient

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: IPIAP-STM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 2, 2018
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.