A Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00883181
First received: April 16, 2009
Last updated: January 25, 2013
Last verified: January 2013

April 16, 2009
January 25, 2013
December 2007
January 2010   (final data collection date for primary outcome measure)
To describe incidence of Febrile Neutropenia (FN) based on Granulocyte Colony Stimulating Factor (G-CSF) (primary, secondary or no usage) use in subjects receiving myelotoxic chemotherapy. [ Time Frame: The duration of the G-CSF use ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00883181 on ClinicalTrials.gov Archive Site
  • To describe the management of patients who are receiving myelotoxic chemotherapy including G-CSF use, ESA use, anti-infective use, transfusions and hospitalisations [ Time Frame: The duration of the chemotherapy plus the five years of long term follow up data ] [ Designated as safety issue: No ]
  • To describe toxicities including febrile neutropenia and anemia [ Time Frame: The duration of the chemotherapy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy
A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy

This is a multi center international observational study of subjects receiving myelotoxic regimens, with an investigator assessed risk of Febrile Neutropenia (FN) ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung). Approximately 100-150 sites will contribute information on 10-15 subjects treated at their institution.

This is a multi center international observational study of subjects receiving myelotoxic regimens, with an investigator assessed risk of FN ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung). Approximately 100-150 sites will contribute information on 10-15 subjects treated at their institution. Sites will be selected where the data specified below is routinely collected for patient management. The selection of sites will be managed to try and represent a selection of various treating centers within each country. However, whilst sites will be encouraged to provide data on patients with all tumor types this will not be enforced and sites or indeed countries may enroll patients to only 1 tumor group. The reason for any site not wishing to participate will be recorded and reported at study end. Approximately 1300 subjects will be recruited . The aim is to have approximately 800 breast cancer, 300 Non-Small Cell Lung Cancer, 100 Small-Cell Lung Cancer and 100 ovarian cancer subjects.

Observational
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

This is an observational study. No bio-specimens are being collected.

Probability Sample

Subjects greater than or equal to 18 years old. Subjects with breast, ovarian or lung cancer. Subjects receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.

Subjects with Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines).

Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).

Written subject consent (where required by local law).

  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Small Cell Lung Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1370
November 2014
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
  • These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 EORTC G-CSF Guidelines

Exclusion Criteria:

- Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00883181
20060445
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP