Nivestim™ in Treatment of Malignant Diseases

July 23, 2015 updated by: Hospira, now a wholly owned subsidiary of Pfizer

The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases

The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).

Study Type

Observational

Enrollment (Actual)

386

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ahaus, Germany, 48683
        • Facharzt für Innere Medizin, Onkologie, Hämatologie
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Hämatologie/Onkologie/Diabetologie
      • Bad Säckingen, Germany, 79713
        • Facharzt für Innere Medizin Hämatologie / Onkologie
      • Berlin, Germany, 10367
        • MediOnko-Institut GbR
      • Berlin, Germany, 13055
        • Onkoplan GmbH/Onkologische Schwerpunkpraxis
      • Chemnitz, Germany, 09117
        • FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie
      • Delitzsch, Germany, 04509
        • MVZ Delitzsch GmbH
      • Dortmund, Germany, 44263
        • Gesellschaft für onkologische Studien Dortmund mbH
      • Dresden, Germany, 01307
        • Gemeinschaftspraxis
      • Düsseldorf, Germany, 40479
        • Gemeinschaftspraxis Haematologie/Medizin Onkologie
      • Eisenach, Germany, 99817
        • Gemeinschaftspraxis
      • Frankfurt/Main, Germany, 60486
        • Krankenhaus Nordwest GmbH Institut für klinische Forschung
      • Garbsen, Germany, 30827
        • Internist - Hämatologe - Onkologe
      • Gütersloh, Germany, 33332
        • Onkodok GmbH
      • Hamburg, Germany, 20095
        • Fachärztin für Allgemeinmedizin
      • Hamburg, Germany, 22765
        • Facharzt für Innere Medizin
      • Hannover, Germany, 30625
        • Internist - Hämatologe - Onkologe
      • Heidenheim, Germany, 89518
        • ODZ-Petersen GmbH
      • Herne, Germany, 44623
        • DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
      • Krefeld, Germany, 47805
        • ZAGO
      • Leipzig, Germany, 04357
        • Pneumologisch/onkologisch/internistisches Studienzentrum
      • Leipzig, Germany, 04107
        • FA f. Frauenheilkunde und Geburtshilfe
      • Lippstadt, Germany, 59555
        • Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin
      • Mainz, Germany, 55131
        • Praxis für Innere Medizin, Hämatologie und Onkologie
      • Minden, Germany, 32429
        • Johannes Esling Klinikum Minden
      • Moers, Germany, 47441
        • OnkoLog Moers GbR
      • Munchen, Germany, 80638
        • Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen
      • München, Germany, 81245
        • Forschungs- und Studiengesellschaft HOPE München GmbH
      • Münster, Germany, 48149
      • Neustadt a. Rbge, Germany, 31535
        • FÄ für Innere Medizin Hämatologie/Internistische Onkologie
      • Neustadt/Sachsen, Germany, 01844
        • Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin
      • Nordhausen, Germany, 99734
        • MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe
      • Nürnberg, Germany, 90491
        • Martha-Maria Krankenhaus gGmbH MVZ Onkologie
      • Oelde, Germany, 59302
        • Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie
      • Oldenburg, Germany, 26121
        • Onkologische Praxis Oldenburg/ Delmenhorst
      • Olpe, Germany, 57462
        • Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
      • Osnabrück, Germany, 49076
      • Remscheid, Germany, 42859
        • Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie
      • Rodgau, Germany, 63110
        • Frauenärzte -Naturheilverfahren-
      • Scheibenberg, Germany, 09481
        • Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie
      • Siegburg, Germany, 53721
        • Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH
      • Soest-Paradiese, Germany, 59494
        • Medizinisches Versorgungszentrum GbR
      • Stralsund, Germany, 18435
        • g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.
      • Stuttgart, Germany, 70190
      • Velbert, Germany, 42551
        • Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie
      • Wiesbaden, Germany, 65191
        • Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)
      • Witten, Germany, 58452
        • FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH
      • Zittau, Germany, 02763
        • FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adult patients with a solid tumour or a malignant haematological tumour

Description

Inclusion Criteria:

  • No age limit
  • Declaration of informed consent signed by patient or legal guardian
  • Patients with a solid tumour or with a malignant haematological tumour
  • Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
  • Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN).

Exclusion Criteria:

  • Patients with chronic myeloid leukaemia (CML) or with myelodysplastic Syndrome (MDS)
  • Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™
  • Patients not undergoing chemotherapy
  • Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of hospitalisation due to febrile neutropenia and/or infection
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterisation of patients being treated with Nivestim™
Time Frame: 6 months

Characterisation of patient based on:

  • Socio-demographic data
  • previous medical history (Surgical and therapeutic)
  • Tumour data
  • Chemotherapy data
  • Clinical and laboratory data preceding treatment with Nivestim™
6 months
Treatment with Nivestim™ as part of daily routine
Time Frame: 6 months
  • Therapeutic indication
  • Dosage and mode of administration
  • Duration of treatment (planned and carried through)
  • Delay in start of treatment since last chemotherapy for purposes of prophylaxis
  • Absolute Neutrophil Count (ANC) during study.
6 months
Description of the efficacy of treatment with Nivestim™
Time Frame: 6 months

Description of the efficacy of treatment with Nivestim(TM) which includes the following parameters:

  • Duration of neutropenia
  • Incidence of febrile neutropenia
  • Frequency of infection
  • Delay in chemotherapy cycles due to neutropenia
  • Reduction in chemotherapy doses due to neutropenia
  • Assessment of patient
6 months
Detailed description of tolerability and safety
Time Frame: 6 months
  • Hospitalisation
  • Adverse events
6 months
Description of the characteristics of the participating physicians
Time Frame: During the study initiation visit
Socio-demographic data (age, gender, field of specialisation, structure of practice, title)
During the study initiation visit
Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)
Time Frame: During the study initiation visit
Criteria for selecting Nivestim™
During the study initiation visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (Estimate)

June 26, 2012

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VENICE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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