Clinical trial NCT00277160: A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neutropenia
Breast Cancer
Lung Cancer
Non-Hodgkin's Lymphoma
Ovarian Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 852
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day
timeFrame: End of the last cycle of chemotherapy or the date of early termination from the study
Secondary outcomes:
measure: Incidence of grade 3 and 4 neutropenia
timeFrame: End of the last cycle of chemotherapy or the date of early termination from the study
measure: Dose delays or dose reductions
timeFrame: End of the last cycle of chemotherapy or the date of early termination from the study
measure: Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day
timeFrame: End of the last cycle of chemotherapy or the date of early termination from the study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Balducci L, Al-Halawani H, Charu V, Tam J, Shahin S, Dreiling L, Ershler WB. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist. 2007 Dec;12(12):1416-24. doi: 10.1634/theoncologist.12-12-1416.
citation: Flores IQ, Ershler W. Managing neutropenia in older patients with cancer receiving chemotherapy in a community setting. Clin J Oncol Nurs. 2010 Feb;14(1):81-6. doi: 10.1188/10.CJON.81-86.