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

• ClinicalTrials.gov Identifier: NCT03514381
• Recruitment Status: Active, not recruiting
• First Posted: May 2, 2018
• Last Update Posted: October 14, 2020
• Sponsor: Institut Claudius Regaud
• Information provided by (Responsible Party): Institut Claudius Regaud

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 (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
• Estimated Primary Completion Date: November 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
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 :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Institut Claudius Regaud

More Information

• Responsible Party: Institut Claudius Regaud
• ClinicalTrials.gov Identifier: NCT03514381
• Other Study ID Numbers: 17 SARC 04
• First Posted: May 2, 2018
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Claudius Regaud:

Soft Tissue Sarcoma; Ifosfamide; Aprepitant; Doxorubicin

Additional relevant MeSH terms:

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