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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574235
• Other study ID #: NEXT
• Status: Completed
• Phase: N/A
• First received: April 4, 2012
• Last updated: July 27, 2015
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2114
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Patients presenting with a solid tumor or a malignant hemopathy,

• Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle),

• Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias

Exclusion Criteria:

• Patients presenting with a chronic myeloproliferative syndrome,

• Patients presenting with a myelodysplastic syndrome,

• Patients showing hypersensitivity to any of the ingredients of Nivestim®,

• Patients not receiving chemotherapy,

• Patients who were already included in the study during a previous chemotherapy line

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chemotherapy-Induced Febrile Neutropenia
• Chemotherapy-induced Febrile Neutropenia (FN)
• Febrile Neutropenia
• Malignant Hemopathy
• Neutropenia
• Solid Tumors

Intervention

Biological:
• Nivestim®

Locations

Country	Name	City	State
France	Ch Du Pays D'Aix	Aix En Provence	Marseille
France	Clinique Rambot	Aix En Provence	Marseille
France	MEDIPOLE	Aix Les Bains	Rhone Alpes
France	CHG	Ales	Languedoc
France	Ico Angers	Angers	Pays de La Loire
France	CHRA	Annecy	Rhone Alpes
France	Victor Dubos	Argenteuil	Paris Nord
France	Clinique des Bonnettes	Arras	Nord
France	Ch Duffaut	Avignon	Marseille
France	CHG	Beziers	Languedoc
France	CH Boulogne-sur-Mer	Boulogne	Nord
France	Clinique Porte St Cloud	Boulogne	Paris Ouest
France	Clinique CONVERT	Bourg en bresse	Rhone Alpes
France	Chr Brive	Brive	Massif Central
France	CHG Cahors	Cahors	Midi Pyrennees
France	CHG	Carcassonne	Languedoc
France	Polyclinique Cesson	Cesson	Basse Normandie
France	CHG William MOREY	Chalon S/s	Bourgogne
France	Ch Chambery	Chambery	Rhone Alpes
France	Ch Cholet	Cholet	Pays de La Loire
France	Chu Estaing	Clermont	Massif Central
France	Chu Gabriel Montpied	Clermont	Massif Central
France	Pole Sante Republique	Clermont	Massif Central
France	BEAUJON	Clichy	Paris Ouest
France	Hopital Louis Pasteur	Colmar	Alsace
France	CHG Dieppe	Dieppe	Haute Normandie
France	CHU du BOCAGE	Dijon	Bourgogne
France	CH de Draguignan	Draguignan	Paca
France	Hopital Jean Monnet	Epinal	Alsace
France	Clinique Pasteur	Evreux	Haute Normandie
France	CHI de Fréjus	Frejus	Paca
France	Chi Frejus - St Raphael	Frejus	Paca
France	CHICAS	GAP	Paca
France	Chu Grenoble	Grenoble	Rhone Alpes
France	Clinique Ste Marguerite	Hyeres	Paca
France	Clinique du Cap d'Or	La Seyne Sur Mer	Paca
France	Hopital Mignot	Le Chesnay	Paris Ouest
France	Ch Le Mans	Le Mans	Pays de La Loire
France	Victor Hugo	Le Mans	Pays de La Loire
France	Hopital Franco Britannique	Levallois Perret	Paris Ouest
France	Centre Oscar Lambret	Lille	Nord
France	Hopital Des Courses	Maisons Laffitte	Paris Ouest
France	Chp Clairval	Marseille
France	Chu Timone	Marseille
France	Fondation Saint Joseph	Marseille
France	Hopital A.Pare	Marseille
France	IPC	Marseille
France	Clinique St Faron	Meaux	Champagne
France	CH Jacques Monod	Montivilliers	Haute Normandie
France	Clinique Vitalia Desertines	Montlucon	Massif Central
France	Chu St Eloi	Montpellier	Languedoc
France	Clinique Beausoleil	Montpellier	Languedoc
France	CH Emile Muller	Mulhouse	Alsace
France	HARTMANN	Neuilly/seine	Paris Ouest
France	Clinique Belvédère	Nice	Paca
France	CHU Caremeau	Nimes	Languedoc
France	Clinique Ste Marie	Osny	Paris Nord
France	Saint Antoine	Paris	Paris Nord
France	Saint Louis	Paris	Paris Nord
France	TENON	Paris	Paris Nord
France	Chg St Jean	Perpignan	Languedoc
France	Hpt Rene Dubos	Pontoise	Paris Nord
France	Cac Jean Godinot	Reims	Champagne
France	Chu Rennes	Rennes	Basse Normandie
France	CHU SUD	Rennes	Basse Normandie
France	Clinique St Laurent	Rennes	Basse Normandie
France	CHR	Roanne	Massif Central
France	Centre frederic joliot curie	Rouen	Haute Normandie
France	Centre Rene Huguenin	St Cloud	Paris Ouest
France	Icl St Etienne	St Etienne	Massif Central
France	CHG St Gaudens	St Gaudens	Midi Pyrennees
France	Chp St Greg	St Gregoire	Basse Normandie
France	Ch St Malo	St Malo	Basse Normandie
France	Hopital St Quentin	St Quentin	Champagne
France	CAC Paul Strauss	Strasbourg	Alsace
France	Chu Hopital Civil	Strasbourg	Alsace
France	STE ANNE	Strasbourg	Alsace
France	Hopital Foch	Suresnes	Paris Ouest
France	Clinique de l'Ormeau	Tarbes	Midi Pyrennees
France	CH Sainte Musse	Toulon	Paca
France	H.I.A Saint Anne	Toulon	Paca
France	CHU Purpan	Toulouse	Midi Pyrennees
France	Clinique Pasteur	Toulouse	Midi Pyrennees
France	Inst. Claudius Regaud	Toulouse	Midi Pyrennees
France	Hopital Troyes	Troyes	Champagne
France	Ch Valence	Valence	Rhone Alpes
France	Clinique des Dentellieres	Valenciennes	Nord

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	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	Yes
Secondary	Efficacy of treatment with Nivestim®	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)	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	No
Secondary	Characteristics of the patients treated with Nivestim® in real-life practice	Describe the characteristics of the patients treated with Nivestim® in real-life practice,	At Visit 1	No
Secondary	Methods of treatment with Nivestim®	Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice.	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	No
Secondary	Profiles of the physicians participating in the study	Describe the profiles of the physicians participating in the study	At visit 1	No
Secondary	General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)	Assess the general practice of these physicians with regard to prescription of G-CSF	At visit 1	No