Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005865
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2000-06-02
Brief Title:
Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
GlaxoSmithKline
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Research Study Evaluating Oral and Intravenous NAVELBINE as a Single Agent for the Treatment of Chemotherapy-Naive Subjects With Inoperable Stage IIIb or Stage IV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
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 Giving drugs in different ways may kill more tumor cells It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the safety and efficacy of oral versus intravenous vinorelbine in patients with stage IIIB or IV non-small cell lung cancer II Compare the quality of life of patients treated with these regimens III Compare the pharmacokinetics of these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive oral vinorelbine weekly Arm II Patients receive vinorelbine IV over 10 minutes weekly Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed several times during treatment and 4 weeks after treatment Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A maximum of 195 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive oral vinorelbine weekly Arm II Patients receive vinorelbine IV over 10 minutes weekly Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed several times during treatment and 4 weeks after treatment Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A maximum of 195 patients will be accrued for this study
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 |
|---|---|---|---|
| GW-VINA2004 | None | None | None |