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

Primary Purpose

Soft Tissue Sarcoma

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Patients starting a treatment with Doxorubicin and Ifosfamide
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Soft Tissue Sarcoma, Ifosfamide, Aprepitant, Doxorubicin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Bergonie
  • Institut Regional Du Cancer de Montpellier (Icm)
  • Institut Universitaire Du Cancer de Toulouse - Oncopole

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients starting a treatment with Doxorubicin and Ifosfamide

Arm Description

Outcomes

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)

Secondary Outcome Measures

Toxicity assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Evolution of plasma concentrations of ifosfamide and its serum metabolites between the first and second cycles
The rate of objective responses determined according to the criteria RECIST v 1.1

Full Information

First Posted
April 20, 2018
Last Updated
January 11, 2021
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT03514381
Brief Title
Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma
Acronym
IPIAP-STM
Official Title
Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
Soft Tissue Sarcoma, Ifosfamide, Aprepitant, Doxorubicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients starting a treatment with Doxorubicin and Ifosfamide
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Patients starting a treatment with Doxorubicin and Ifosfamide
Intervention Description
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)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
The rate of objective responses determined according to the criteria RECIST v 1.1
Time Frame
Cycle 3 Day 1 for each patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Regional Du Cancer de Montpellier (Icm)
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Universitaire Du Cancer de Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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