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

October 7, 2010 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

852

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1 (Primary Prophylaxis)
Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1
Drug: Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
Active Comparator: Treatment Group 2 (Secondary Prophylaxis)
Per Investigator's discretion
Drug: Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of the last cycle of chemotherapy or the date of early termination from the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
End of the last cycle of chemotherapy or the date of early termination from the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

October 8, 2010

Last Update Submitted That Met QC Criteria

October 7, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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