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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277160
• Other study ID #: 20020122
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2006
• Last updated: October 7, 2010
• Start date: June 2002
• Est. completion date: January 2005

Study information

• Verified date: October 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: January 2005
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incidence of grade 3 and 4 neutropenia		End of the last cycle of chemotherapy or the date of early termination from the study	Yes
Secondary	Dose delays or dose reductions		End of the last cycle of chemotherapy or the date of early termination from the study	Yes
Secondary	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	Yes

External Links

•   AmgenTrials clinical trials website