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| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00094822 |
Purpose
The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be "investigational" because previous studies with Neulasta® used next day dosing and not same day dosing.
| Condition | Intervention |
|---|---|
|
Lung Cancer Non-Small Cell Lung Cancer |
Other: PI Discretion |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Pegfilgrastim Given Same Day as or Day After Carboplatin and Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer |
| Enrollment: | 90 |
| Study Start Date: | July 2003 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Pegfilgrastim |
Other: PI Discretion
PI Discretion
|
| PLACEBO |
Other: PI Discretion
PI Discretion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Advanced or Metastatic NSCLC
Eligibility Criteria: - Age 18 years or older - Diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) - Have not received any prior chemotherapy - Have not received radiation therapy or undergone major surgery within the past 2 weeks
Contacts and Locations More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20030123 |
| Study First Received: | October 27, 2004 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00094822 |
| Health Authority: | United States: Food and Drug Administration |
|
Metastatic Cancer Neulasta® pegfilgrastim |
|
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Neoplasm Metastasis Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
