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A Pilot Study of the Effects of Neutropenia on Patient Reported Outcomes During Chemotherapy With or Without Neulasta® (Pegfilgrastim) in Subjects With Advanced NSCLC


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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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

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