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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neutropenia, Breast Cancer, Lung Cancer, Non-Hodgkin's Lymphoma, Ovarian Cancer

Intervention / Treatment
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* Drug: Neulasta (pegfilgrastim)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |