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

Phase 4

Completed

• Conditions: Neutropenia; Breast Cancer; Lung Cancer; Non-Hodgkin's Lymphoma; Ovarian Cancer
• Interventions: Drug: Neulasta (pegfilgrastim)

• Registration Number: NCT00277160
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2004-11
• Study Completion: 2005-01
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-16
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-07
• Last Update Posted: 2010-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 852

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group 1 (Primary Prophylaxis)	Neulasta (pegfilgrastim)	Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1
Treatment Group 2 (Secondary Prophylaxis)	Neulasta (pegfilgrastim)	Per Investigator's discretion

Primary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day	End of the last cycle of chemotherapy or the date of early termination from the study

Secondary Outcome Measures

Name	Time	Method
Incidence of grade 3 and 4 neutropenia	End of the last cycle of chemotherapy or the date of early termination from the study
Dose delays or dose reductions	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	End of the last cycle of chemotherapy or the date of early termination from the study