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
  Purpose

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.


Condition
Breast Cancer
Non-Small Cell Lung Cancer
Ovarian Cancer
Small Cell Lung Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

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


Enrollment: 1370
Study Start Date: December 2007
Estimated Study Completion Date: November 2014
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).

Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883181

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00883181     History of Changes
Other Study ID Numbers: 20060445
Study First Received: April 16, 2009
Last Updated: January 25, 2013
Health Authority: Australia: Human Research Ethics Committee
Canada: Health Canada
Czech Republic: State Institute of Drug Control
Finland: Lääkelaitos
Greece: National Organization for Medicines
Italy: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neutropenia
Ovarian Neoplasms
Small Cell Lung Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 16, 2014