Clinical Trial: Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice

Brief Summary: The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

Detailed Summary:
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer

Current Primary Outcome: Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy. [ Time Frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months ]

The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection.


Original Primary Outcome: Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with toxic chemotherapeutic agents for solid tumors or hematological malignancies. [ Time Frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months ]

The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection.


Current Secondary Outcome:

  • Efficacy of treatment with Nivestim® [ Time Frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months ]
    Assess the efficacy of the treatment with Nivestim® by studying occurrence of febrile neutropenia, infection and the impact of these events on the chemotherapy treatment (cycle postponement, dose reduction)
  • Characteristics of the patients treated with Nivestim® in real-life practice [ Time Frame: At Visit 1 ]
    Describe the characteristics of the patients treated with Nivestim® in real-life practice,
  • Methods of treatment with Nivestim® [ Time Frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months ]
    Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice.
  • Profiles of the physicians participating in the study [ Time Frame: At visit 1 ]
    Describe the profiles of the physicians participating in the study
  • General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF) [ Time Frame: At visit 1 ]
    Assess the general practice of these physicians with regard to prescription of G-CSF


Original Secondary Outcome: Efficacy and respect of Nivestim® treatment indications.

Febrile neutropenia and infection occurence, chemotherapy cycle deferral due to neutropenia, chemotherapy dose reduction due to neutropenia.

Socio-demographic data, therapeutic, surgical and medical history, malignancies data, biological parameters before Nivestim® treatment, modalities of chemotherapy.

Treatment indication, febrile neutropenia characteristics if it is curative treatment, dosage and route of administration, delay of treatment initiation, treatment duration, WBC count on the last day of treatment.



Information By: Hospira, now a wholly owned subsidiary of Pfizer

Dates:
Date Received: April 4, 2012
Date Started: October 2011
Date Completion:
Last Updated: July 27, 2015
Last Verified: July 2015