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

NCT00277160 | Completed Phase 4

• 1 other identifier: 20020122
• Study Type: interventional
• Target: 852
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Treatment Group 1 (Primary Prophylaxis)

EXPERIMENTAL

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

Drug: Neulasta (pegfilgrastim)

Treatment Group 2 (Secondary Prophylaxis)

ACTIVE COMPARATOR

Per Investigator's discretion

Drug: Neulasta (pegfilgrastim)

Interventions

Neulasta (pegfilgrastim) DRUG

Commercial pegfilgrastim 6mg single subcutaneous fixed-dose

Treatment Group 1 (Primary Prophylaxis); Treatment Group 2 (Secondary Prophylaxis)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>/= 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Amgen: lead

Related 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.

  PMID: 18165618 RESULT

• 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.

  PMID: 20118030 RESULT

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neutropenia; Breast Neoplasms; Lung Neoplasms; Lymphoma, Non-Hodgkin; Ovarian Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 16, 2006
• Study Start: June 1, 2002
• Primary Completion: November 1, 2004
• Study Completion: January 1, 2005
• Last Updated: October 8, 2010

Record last verified: 2010-10