A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer

The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.

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Key information

Conditions

Neutropenia Adnexal Diseases Agranulocytosis Breast Cancer Breast Diseases Breast Neoplasms Cytopenia Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukocyte Disorders Leukopenia Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non-Hodgkin's Lymphoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>/= 65 years old
documented diagnosis of lung, breast, or ovarian cancer, or NHL
scheduled to receive one of 15 standard chemotherapy regimens
chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease
life expectancy of at least 3 months
ECOG performance status </=2
adequate renal and hematologic function
informed consent for participation in the study prior to any study specific procedures

Exclusion criteria

known hypersensitivity to any of the products to be administered during dosing
primary prophylactic antibiotics in all cycles
prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases
prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation
clinically symptomatic brain metastases
Folstein mini-mental state exam score <18
Any premalignant myeloid condition or any malignancy with myeloid characteristics
History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies
unstable/uncontrolled cardiac conditions or hypertension
active infection
subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents

Treatment and study plan

Neulasta (pegfilgrastim)

Drug

Commercial pegfilgrastim 6mg single subcutaneous fixed-dose

Primary outcomes

Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day

Time frame: End of the last cycle of chemotherapy or the date of early termination from the study

Secondary outcomes

Incidence of grade 3 and 4 neutropenia

Time frame: End of the last cycle of chemotherapy or the date of early termination from the study
Dose delays or dose reductions

Time frame: End of the last cycle of chemotherapy or the date of early termination from the study
Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day

Time frame: End of the last cycle of chemotherapy or the date of early termination from the study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Open Label, Multicenter Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2005
First posted: Jan 16, 2006
Registry last updated: Oct 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed