IPIAP-STM: Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Completed

CT.gov ID

NCT03514381

Collaborator

(none)

Enrollment

Locations

Arm

30.2

Actual Duration (Months)

19.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma	Drug: Patients starting a treatment with Doxorubicin and Ifosfamide	Phase 4

Study Design

Study Type:

Interventional

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 :

Nov 23, 2020

Actual Study Completion Date :

Nov 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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: Cycle 1 (Day 1-Day 2-Day 3) Cycle 2 (Day 1-Day 2-Day 3)

Arm

Intervention/Treatment

Other: 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: Cycle 1 (Day 1-Day 2-Day 3) Cycle 2 (Day 1-Day 2-Day 3)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut Bergonie	Bordeaux	France	33076
2	Institut Regional Du Cancer de Montpellier (Icm)	Montpellier	France	34298
3	Institut Universitaire Du Cancer de Toulouse - Oncopole	Toulouse	France	31059