Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006215
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2000-09-11
Brief Title:
Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Amgen
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Docetaxel and Vinorelbine in Advanced Non-Small Cell Lung Carcinoma
Status:
UNKNOWN
Status Verified Date:
2001-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the response to docetaxel and vinorelbine with filgrastim G-CSF support in patients with stage IIIB or IV non-small cell lung cancer II Determine the toxicity of this regimen in these patients III Determine the overall survival and time to tumor progression in patients treated with this regimen
OUTLINE This is a multicenter study Patients receive vinorelbine IV over 6-10 minutes and docetaxel IV over 1 hour on day 1 and filgrastim G-CSF subcutaneously daily on days 2-12 or until blood counts recover Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 1 year
OUTLINE This is a multicenter study Patients receive vinorelbine IV over 6-10 minutes and docetaxel IV over 1 hour on day 1 and filgrastim G-CSF subcutaneously daily on days 2-12 or until blood counts recover Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1596 | None | None | None |
| AMGEN-GCSF-990138 | None | None | None |