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

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ClinicalTrials.gov Identifier: NCT00277160
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : October 8, 2010
Sponsor:
Information provided by:
Amgen

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.

Condition or disease Intervention/treatment Phase
Neutropenia Breast Cancer Lung Cancer Non-Hodgkin's Lymphoma Ovarian Cancer Drug: Neulasta (pegfilgrastim) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 852 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2002
Actual Primary Completion Date : November 2004
Actual Study Completion Date : January 2005


Arm Intervention/treatment
Experimental: Treatment Group 1 (Primary Prophylaxis)
Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1
Drug: Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose

Active Comparator: Treatment Group 2 (Secondary Prophylaxis)
Per Investigator's discretion
Drug: Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose




Primary Outcome Measures :
  1. Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day [ Time Frame: End of the last cycle of chemotherapy or the date of early termination from the study ]

Secondary Outcome Measures :
  1. Incidence of grade 3 and 4 neutropenia [ Time Frame: End of the last cycle of chemotherapy or the date of early termination from the study ]
  2. Dose delays or dose reductions [ Time Frame: End of the last cycle of chemotherapy or the date of early termination from the study ]
  3. Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day [ Time Frame: End of the last cycle of chemotherapy or the date of early termination from the study ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277160


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00277160     History of Changes
Other Study ID Numbers: 20020122
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: October 8, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neutropenia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases