CompletedNot Applicable

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

1,370 participantsStarted 2006-11

Plain-language summary

The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 European Organisation for Research and Treatment of Cancer (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).

What they're measuring

Percentage of Participants With Febrile Neutropenia (FN)

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia

Trial details

NCT IDNCT00883181

SponsorAmgen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2009-10

Results submitted2016-03-10

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants With Febrile Neutropenia (FN)

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia