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

Amgen

Status and phase: Completed; Phase 4

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

Treatments: Drug: Neulasta (pegfilgrastim)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00277160

20020122

Details and patient eligibility

About

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.

Enrollment: 852 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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852 participants in 2 patient groups

Treatment Group 1 (Primary Prophylaxis)

Experimental group

Description:

Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1

Treatment:

Drug: Neulasta (pegfilgrastim)

Treatment Group 2 (Secondary Prophylaxis)

Active Comparator group

Description:

Per Investigator's discretion

Treatment:

Drug: Neulasta (pegfilgrastim)