Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
NCT ID: NCT01459653
Last Updated: 2016-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
1496 participants
OBSERVATIONAL
2010-03-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Only 1 group
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with one of the following types and stages of tumors: stage III or IV breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large B-cell lymphoma; multiple myeloma.
* Planned to receive primary prophylaxis with filgrastim biosimilar (EP2006) at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with filgrastim biosimilar (EP2006) irrespective of chemotherapy cycle.
* Treated with commercially available filgrastim biosimilar per physician's best clinical judgment and per current European filgrastim biosimilar (EP2006) label.
* Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
* Informed written consent to participate in the study by patients or their legal guardian.
Exclusion Criteria
* Sensitivity to filgrastim biosimilar or any other CSF.
* Hypersensitivity to E. coli-derived proteins.
* Radiotherapy to ≥ 20% of total body bone.
* Infection within two weeks of starting current line of chemotherapy.
* Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
* Patients with willfully negligent nonadherence to their cancer treatment.
* Use of any investigational agent in the 30 days prior to enrollment.
* Women of childbearing potential not using the contraception method(s) described above.
* Women who are breastfeeding.
18 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Principal Investigators
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Sandoz GmBH
Role: STUDY_CHAIR
Sandoz GmbH
Locations
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Sandoz Investigational Site
Innsbruck, , Austria
Sandoz Investigational Site
Kufstein, , Austria
Sandoz Investigational Site
Leoben, , Austria
Sandoz Investigational Site
Deurne, , Belgium
Sandoz Investigational Site
Tournai, , Belgium
Sandoz Investigational Site
Cheb, , Czechia
Sandoz Investigational Site
Chomutov, , Czechia
Sandoz Investigational Site
Prague, , Czechia
Sandoz Investigational Site
Teplice, , Czechia
Sandoz Investigational Site
Vítkovice, , Czechia
Sandoz Investigational Site
Agen, , France
Sandoz Investigational Site
Arras, , France
Sandoz Investigational Site
Avignon, , France
Sandoz Investigational Site
Bayonne, , France
Sandoz Investigational Site
Beauvais, , France
Sandoz Investigational Site
Blois, , France
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Bois-Guillaume, , France
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Bordeaux, , France
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Boulogne-sur-Mer, , France
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Brest, , France
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Colmar, , France
Sandoz Investigational Site
Compiègne, , France
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Gap, , France
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Grenoble, , France
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Libourne, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Melun, , France
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Montauban, , France
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Montpellier, , France
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Nancy, , France
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Nîmes, , France
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Orléans, , France
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Paris, , France
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Perpignan, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Reims, , France
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Sainte-Foy-lès-Lyon, , France
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Strasbourg, , France
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Berlin, , Germany
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Chemnitz, , Germany
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Coburg, , Germany
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Dortmund, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Gera, , Germany
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Hamburg, , Germany
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Heinsberg, , Germany
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Herne, , Germany
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Langen, , Germany
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Lehrte, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Munich, , Germany
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Mülheim A. D. Ruhr, , Germany
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Weiden, , Germany
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Wismar, , Germany
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Witten, , Germany
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Wolfsburg, , Germany
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Würselen, , Germany
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Budapest, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Pécs, , Hungary
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Szekszárd, , Hungary
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Szombathely, , Hungary
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Avezzano, , Italy
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Avola, , Italy
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Bari, , Italy
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Campobasso, , Italy
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Colleferro, , Italy
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Cosenza, , Italy
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Cuneo, , Italy
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Frosinone, , Italy
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Gaeta, , Italy
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Genova, , Italy
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La Spezia, , Italy
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Matera, , Italy
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Milan, , Italy
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Monza, , Italy
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Rieti, , Italy
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Roma, , Italy
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S. Giovanni Rotondo, , Italy
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Sora, , Italy
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Torino, , Italy
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Bialystok, , Poland
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Brzozów, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Przemyśl, , Poland
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Warsaw, , Poland
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Wodzisław Śląski, , Poland
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Bucharest, , Romania
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Suceava, , Romania
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Târgu Mureş, , Romania
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Timișoara, , Romania
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Alicante, , Spain
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Barcelona, , Spain
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Benidorm Alicante, , Spain
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Bilbao, , Spain
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Donostia / San Sebastian, , Spain
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La Rioja, , Spain
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Lorca, , Spain
Sandoz Investigational Site
Pamplona, , Spain
Sandoz Investigational Site
Valencia, , Spain
Sandoz Investigational Site
Vitoria-Gasteiz, , Spain
Sandoz Investigational Site
Genolier, , Switzerland
Sandoz Investigational Site
Zurich, , Switzerland
Sandoz Investigational Site
Cottingham, , United Kingdom
Sandoz Investigational Site
Liverpool, , United Kingdom
Sandoz Investigational Site
Rotherham, , United Kingdom
Sandoz Investigational Site
Scunthorpe, , United Kingdom
Countries
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Other Identifiers
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EP06-502
Identifier Type: -
Identifier Source: org_study_id
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