Trial Information

Summary: Use of Neulasta with chemotherapy in elderly patients with cancer

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.

Purpose: The purpose of this research study is to compare the effectiveness of Neulasta™ given with each cycle of your chemotherapy starting with the first cycle (also referred to as primary prophylaxis) versus secondary prophylaxis treatment based on your study doctor’s discretion.

You may be eligible to participate in this study if you:

• Are 65 years of age or older
• Have documented cancer of the lung, breast, ovary, or non-Hodgkin’s lymphoma
• Have completed any chemotherapy exposure more than 4 weeks before entry into the study

• Have a known hypersensitivity to any of the study drugs
• Have had a prior radiation therapy within the last 2 weeks or plan for radiation therapy during your participation in this study
• Have had a bone marrow or stem cell transplant or plan to receive transplant therapy during your participation in this study
• Have clinical evidence of brain cancer
• Have a history of prior cancer within the past 5 years other than your original cancer diagnosis with the exception of basal cell cancer, squamous cell cancer, cervical cancer or surgically cured cancers
• Have an active infection
• Have any of the following conditions: uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction or serious uncontrolled cardiac arrhythmia

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Trial listings updated: June 1, 2008 at 5:43:25 AM