Soft tissue sarcoma (localized, local recidive or metastatic) MedDRA version: 20.0 Level: PT Classification code 10075333 Term: Soft tissue sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IFOSFAMIDE EG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IFOSFAMIDE
CAS Number: 3778-73-2
Trade Name: DOXORUBICINE (All generics can be used)
Pharmaceutical Form: Sol
Sponsors
INSTITUT CLAUDIUS REGAUD
Eligibility
Sex/Gender
All
Inclusion 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: a) Hemoglobin > 9.0 g/dL, Neutrophils > 1500/mm3, Platelets > 100000/mm3 b) Creatinine clearance (MDRD formula) > 60ml/min. c) AST/ALT =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 a. Active infection b. Active hepatitis or cirrhosis c. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to show that in patients treated with the association doxorubicin and Ifosfamide for an STM, the plasma concentrations of 2d-Ifo are increased by the co-administration of Aprepitant.;Secondary Objective: The secondary objectives are the following: • Compare the frequency and intensity of adverse events (according to CTCAE v 4.03) occurring in patients exposed to Aprepitant to those occurring in unexposed patients • Compare the plasma concentrations of ifosfamide and its serum metabolites (4OH-IFO, 2d-IFO, 3d-Ifo, CAA) of patients co-exposed to Aprepitant, to those of patients not exposed to this molecule • Assess the impact of co-medications on the occurrence of adverse events • Assess the impact of serum albumin on the occurrence of adverse events • Assess the rate of objective responses (if applicable) • Perform an analysis of population pharmacokinetics including all data (cycle 1 and Cycle 2) by evaluating the impact of the Covariate "co-administration Aprepitant ". ;Primary end point(s): The primary endpoint is the 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).;Timepoint(s) of evaluation of this end point: Cycle 2 Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: - Toxicity is assessed according to the NCI-CTC version 4.03 - The evolution of plasma concentrations of ifosfamide and its serum metabolites (4OH-IFO, 2d-IFO, 3d-Ifo, CAA) between the first and second cycles. - In case of an evaluable disease, the rate of objective responses will be determined according to the criteria RECIST v 1.1 (if applicable). An objective response is defined by a complete or partial response. ;Timepoint(s) of evaluation of this end point: Cycle 3 Day 1 | — |
Countries
France
Contacts
Public ContactCoordinating Investigator
INSTITUT UNIVERSITAIRE DU CANCER TOULOUSE - ONCOPOLE
Outcome results
None listed