A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
NCT ID: NCT00277160
Last Updated: 2010-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
852 participants
INTERVENTIONAL
2002-06-30
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Treatment Group 1 (Primary Prophylaxis)
Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1
Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
Treatment Group 2 (Secondary Prophylaxis)
Per Investigator's discretion
Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
Interventions
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Neulasta (pegfilgrastim)
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20020122
Identifier Type: -
Identifier Source: org_study_id