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

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ClinicalTrials.gov Identifier: NCT03514381
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
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 : June 2020
Estimated Study Completion Date : July 2020


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)




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514381


Contacts
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Contact: Thibaud VALENTIN, MD 05 31 15 51 51 valentin.thibaud@iuct-oncopole.fr

Locations
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France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Maud TOULMONDE, MD    05 56 33 32 78    m.toulmonde@bordeaux.unicancer.fr   
Institut Regional Du Cancer de Montpellier (Icm) Recruiting
Montpellier, France, 34298
Contact: Nelly FIRMIN, MD    04 67 61 45 65    nelly.firmin@icm.unicancer.fr   
Institut Universitaire Du Cancer de Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Thibaud VALENTIN, MD    05 31 15 51 51    valentin.thibaud@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03514381     History of Changes
Other Study ID Numbers: 17 SARC 04
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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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:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Ifosfamide
Isophosphamide mustard
Aprepitant
Fosaprepitant
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents