Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy
Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: Neulasta® (pegfilgrastim) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Summary
The purpose of this study is to estimate the relationship between patient reported outcomes
(PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with
or without Neulasta® (pegfilgrastim).
Clinical Details
Official title: A Pilot Study of the Effects of Neutropenia on Patient Reported Outcomes During Chemotherapy With or Without Neulasta® (Pegfilgrastim) in Subjects With Advanced NSCLC
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Quality of Life
Secondary outcome: Quality of Life, *Neutropenia, *Hospitalization, *Disease Response
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: - Non-small cell lung cancer, not previously treated with chemotherapy or radiotherapy - ECOG performance status 0 or 1 - ANC greater than or equal to 2. 0 x 10^9/L Exclusion Criteria: - Cancer other than NSCLC within 5 years of enrollment, with the exception of surgically cured basal cell carcinoma or in situ carcinoma of the cervix - Treatment less than or equal to 30 days prior with any experimental agent - Subjects with symptomatic brain metastases - Subject is currently enrolled or has not yet completed at
least 30 days since ending other investigational device or drug trial(s) or is receiving
other investigational agent(s)
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Starting date: July 2002
Ending date: July 2004
Last updated: December 20, 2007
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