Breast Cancer, Lung Cancer, Neutropenia, Non-Hodgkin's Lymphoma, Ovarian Cancer
Conditions
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.
Interventions
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed