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

NCT ID: NCT03514381

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-18
• Study Completion Date: 2020-11-23

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients starting a treatment with Doxorubicin and Ifosfamide

Group Type: OTHER

Patients starting a treatment with Doxorubicin and Ifosfamide

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Bergonie

Bordeaux, , France

Institut Regional Du Cancer de Montpellier (Icm)

Montpellier, , France

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, , France

Countries

France

Other Identifiers

17 SARC 04

Identifier Type: -

Identifier Source: org_study_id