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

Soft Tissue Sarcoma Clinical Trial

— IPIAP-STM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514381
• Other study ID #: 17 SARC 04
• Status: Completed
• Phase: Phase 4
• Start date: May 18, 2018
• Est. completion date: November 23, 2020

Study information

• Verified date: January 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or metastatic).

3. Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative treatment).

4. Screening laboratory values must meet the following criteria:

1. Hemoglobin > 9.0 g/dL, Neutrophils > 1500/mm3, Platelets > 100000/mm3

2. Creatinine clearance (MDRD formula) > 60ml/min.

3. AST/ALT < 2.5 x ULN (5 x ULN in patients with hepatic metastasis).

5. Evaluable disease (measurable per RECIST or not), if applicable.

6. Patient must provide written informed consent prior to any study specific procedures.

7. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Previous treatment with Ifosfamide.

2. Patient who has already started doxorubicin and ifosfamide treatment.

3. Any medical condition that can increase the patient's risk

1. Active infection

2. Active hepatitis or cirrhosis

3. Recipients of organ transplants or immunocompromised patients, including Human Immunodeficiency Virus (HIV) infection

4. Pregnant or breastfeeding women

5. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure

6. Patient protected by law

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

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)

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	Institut Regional Du Cancer de Montpellier (Icm)	Montpellier
France	Institut Universitaire Du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evolution of plasma concentrations of ifosfamide and its serum metabolites between the first and second cycles		Cycle 3 Day 1 for each patient
Secondary	The rate of objective responses determined according to the criteria RECIST v 1.1		Cycle 3 Day 1 for each patient