Various G-CSF Regimens to Prevent Infection During Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536081
Recruitment Status : Terminated (More cases of Febrile Neutropenia were observed in experimental group compared to standard treatment.)
First Posted : September 27, 2007
Last Update Posted : December 23, 2009
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Academisch Ziekenhuis Maastricht

Brief Summary:

The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious [1-3]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to patients at a more than 20% risk of febrile neutropenia.

Based on many positive and few negative trials, one can consider the use of taxanes as standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or without anthracyclines) have an increased risk for febrile neutropenia.

The updated guidelines and changes in daily clinical practice will have a significant impact on the investigators health care resources. There is a higher risk of febrile neutropenia for the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer patients. Also in advanced breast cancer the majority of first observed episodes of febrile neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely seems to disappear.

So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy cycles as compared to the current practice of continuous G-CSF prophylaxis.

Condition or disease Intervention/treatment Phase
Breast Cancer Chemotherapy Febrile Neutropenia Drug: pegfilgrastim Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Primary G-CSF Prophylaxis During the First Two Cycles Only or Throughout All Chemotherapy Cycles in Breast Cancer Patients at Risk of Febrile Neutropenia
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Pegfilgrastim during all 6 cycles of chemotherapy
Drug: pegfilgrastim
6 mg s.c. 24-36 h post-chemotherapy
Experimental: B
Pegfilgrastim during the first two cycles of chemotherapy
Drug: pegfilgrastim
6 mg s.c. 24-36 h post-chemotherapy

Primary Outcome Measures :
  1. number of febrile neutropenia episodes costs per treatment arm [ Time Frame: 18 weeks (all chemotherapy cycles) ]

Secondary Outcome Measures :
  1. Febrile neutropenia rates per cycle number. Other haematological and non-haematological toxicities. Number of chemotherapy cycles delivered. Dose and dose-intensity of chemotherapy. Disease progression. Number of toxic deaths per treatment arm. [ Time Frame: 18 weeks (all chemotherapy cycles) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Breast cancer patients ≥18 years.
  • Indication for 3-weekly chemotherapy.
  • Considered fit enough to receive chemotherapy, with adequate renal and hepatic function.
  • Planned a chemotherapy regime in adjuvant, neo-adjuvant, advanced setting with an increased risk of febrile neutropenia, i.e.:
  • Regimes with >20% risk of febrile neutropenia:

    • e.g. TAC (docetaxel, adriamycin, cyclophosphamide)
    • AT (adriamycin, docetaxel)
  • Regimes with 10-20% risk of febrile neutropenia (e.g. AC, doxorubicin and vinorelbine, or docetaxel monotherapy) in the presence of ≥1 patient risk factor (>65 yrs, extensive bone marrow involvement or prior extensive radiotherapy on bone tissue
  • Prior chemotherapy
  • ECOG performance status of 2 or more, grade 2 or higher liver function abnormalities).
  • That is, patients starting with docetaxel as second part of FEC-D are eligible for the last 3 docetaxel cycles, if there is an increased risk of febrile neutropenia, e.g. by elderly age.
  • Able to comply with the protocol.
  • Written informed consent obtained prior to any study specific screening.

Exclusion Criteria:

  • Active uncontrolled infection.
  • Inadequate renal or hepatic function.
  • Any evidence or history of hypersensitivity or other contraindications to G-CSF medication.
  • Not recovered from acute toxicities of prior therapies.
  • Absolute neutrophil count (ANC) <1.5 x 109/l, not caused by bone marrow involvement.

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 identifier (NCT number): NCT00536081

Ziekenhuis Rijnstate, Alysis
Arnhem, Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Diaconessenhuis Leiden
Leiden, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
UMC St. Radboud
Nijmegen, Netherlands
Erasmus MC - Daniel den Hoed
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Orbis Medisch Centrum
Sittard, Netherlands
Mesos Medisch Centrum
Utrecht, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
Ziekenhuis Zevenaar, Alysis
Zevenaar, Netherlands
Sponsors and Collaborators
Academisch Ziekenhuis Maastricht
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Vivianne CG Tjan-Heijnen, MD PhD Maastricht University Medical Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. V. Tjan-Heijnen, Academisch Ziekenhuis Maastricht Identifier: NCT00536081     History of Changes
Other Study ID Numbers: 2-2-6 STUDY
ZonMw ID 80-82310-98-08006 ( Other Grant/Funding Number: Stichting ZonMW )
EudraCT number 2007-005402-53 ( Other Identifier: Centrale Commissie Mensgebonden Onderzoek CCMO )
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Academisch Ziekenhuis Maastricht:
Breast cancer
Febrile neutropenia

Additional relevant MeSH terms:
Breast Neoplasms
Febrile Neutropenia
Neoplasms by Site
Breast Diseases
Skin Diseases
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms