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


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Small Cell Lung Cancer

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Trial Information

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 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.


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).

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

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.

Outcome Time Frame:

The duration of the G-CSF use

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Human Research Ethics Committee

Study ID:

20060445

NCT ID:

NCT00883181

Start Date:

December 2007

Completion Date:

November 2014

Related Keywords:

  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Small Cell Lung Cancer
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neutropenia
  • Ovarian Neoplasms
  • Small Cell Lung Carcinoma

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