Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma (IPIAP-STM)
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ClinicalTrials.gov Identifier: NCT03514381 |
Recruitment Status :
Completed
First Posted : May 2, 2018
Last Update Posted : January 12, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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Soft Tissue Sarcoma | Drug: Patients starting a treatment with Doxorubicin and Ifosfamide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma |
Actual Study Start Date : | May 18, 2018 |
Actual Primary Completion Date : | November 23, 2020 |
Actual Study Completion Date : | November 23, 2020 |

Arm | Intervention/treatment |
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Patients starting a treatment with Doxorubicin and Ifosfamide |
Drug: Patients starting a treatment with Doxorubicin and Ifosfamide
9 blood samples will be collected at each Cycle:
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- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514381
France | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
Institut Regional Du Cancer de Montpellier (Icm) | |
Montpellier, France, 34298 | |
Institut Universitaire Du Cancer de Toulouse - Oncopole | |
Toulouse, France, 31059 |
Responsible Party: | Institut Claudius Regaud |
ClinicalTrials.gov Identifier: | NCT03514381 |
Other Study ID Numbers: |
17 SARC 04 |
First Posted: | May 2, 2018 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Soft Tissue Sarcoma Ifosfamide Aprepitant Doxorubicin |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Ifosfamide Antibiotics, Antineoplastic |
Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |