Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003447
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Vinorelbine andor Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Istituto Nazionale per lo Studio e la Cura dei Tumori
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2007-09
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
PURPOSE Randomized phase III trial to compare the effectiveness of vinorelbine gemcitabine or both in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of vinorelbine gemcitabine or both in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the activity and toxicities of gemcitabine in elderly patients with non-small cell lung cancer II Determine the activity and toxicity of the combination of gemcitabine and vinorelbine in these patients III Compare the survival rate and quality of life of these patients treated with combination chemotherapy versus single agent chemotherapy IV Compare objective response and time to progression of these patients treated with these chemotherapy regimens V Compare the toxicities of these three regimens in these patients VI Compare the number of hospitalizations palliative radiation therapies antibiotic therapies corticosteroid therapies analgesic therapies and hematopoietic growth factor therapies needed for these patients treated with these chemotherapy regimens
OUTLINE This is a randomized multicenter study Patients are stratified by center stage of disease IIIB vs IV and performance status 0 vs 1 vs 2 Patients are randomized to one of three treatment arms Patients receive either vinorelbine IV gemcitabine IV or both on days 1 and 8 of each 21 day course Patients who achieve an objective response or stable disease after 3 courses receive 3 more courses for a total of 6 courses Quality of life is assessed before treatment after course 4 or 3 weeks after course 3 if therapy is stopped and at 21 days after course 6 or 12 weeks after course 3
PROJECTED ACCRUAL A total of 630 patients 210 patients per arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified by center stage of disease IIIB vs IV and performance status 0 vs 1 vs 2 Patients are randomized to one of three treatment arms Patients receive either vinorelbine IV gemcitabine IV or both on days 1 and 8 of each 21 day course Patients who achieve an objective response or stable disease after 3 courses receive 3 more courses for a total of 6 courses Quality of life is assessed before treatment after course 4 or 3 weeks after course 3 if therapy is stopped and at 21 days after course 6 or 12 weeks after course 3
PROJECTED ACCRUAL A total of 630 patients 210 patients per arm 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 |
|---|---|---|---|
| EU-98019 | None | None | None |
| ITA-MILES | None | None | None |
| ITA-GOCSI-MILES | None | None | None |