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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883181
• Other study ID #: 20060445
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: February 24, 2016
• Start date: December 2007
• Est. completion date: September 2014

Study information

• Verified date: February 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeCanada: Health CanadaCzech Republic: State Institute of Drug ControlFinland: LääkelaitosGreece: National Organization for MedicinesItaly: Ministry of HealthSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: Swissmedic (Swiss Agency for Therapeutic Products)
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1370
• Est. completion date: September 2014
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		The duration of the G-CSF use	No
Secondary	To describe the management of patients who are receiving myelotoxic chemotherapy including G-CSF use, ESA use, anti-infective use, transfusions and hospitalisations		The duration of the chemotherapy plus the five years of long term follow up data	No
Secondary	To describe toxicities including febrile neutropenia and anemia		The duration of the chemotherapy	No

External Links

•   AmgenTrials clinical trials website