Trial Information
A Pilot Study of the Effects of Neutropenia on Patient Reported Outcomes During Chemotherapy With or Without Neulasta® (Pegfilgrastim) in Subjects With Advanced NSCLC
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Quality of Life
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20020121
NCT ID:
NCT00115206
Start Date:
July 2002
Completion Date:
July 2004
Related Keywords:
- Non-Small Cell Lung Cancer
- Non Small Cell Lung Cancer
- NSCLC
- Fever
- Neutropenia
- Neulasta®
- Quality of Life
- Chemotherapy
- Amgen
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
