Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022022
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-08-10
Brief Title:
Docetaxel in Treating Patients With 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:
Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
Status:
UNKNOWN
Status Verified Date:
2006-04
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 It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy
Compare the toxicity of these regimens in these patients
Compare the response rate time to progression and survival of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to center ECOG performance status 0 vs 1 vs 2 response to prior chemotherapy partial or complete response vs stable disease vs progressive disease and prior cisplatin-containing chemotherapy regimen yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV on day 1 Treatment continues every 3 weeks for a maximum of 6 courses
Arm II Patients receive docetaxel IV weekly for 6 weeks Treatment continues every 8 weeks for a maximum of 2 courses
Quality of life is assessed at baseline and days 22 and 43-56 for arm I and at baseline and days 22 and 43 for arm II
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy
Compare the toxicity of these regimens in these patients
Compare the response rate time to progression and survival of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to center ECOG performance status 0 vs 1 vs 2 response to prior chemotherapy partial or complete response vs stable disease vs progressive disease and prior cisplatin-containing chemotherapy regimen yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV on day 1 Treatment continues every 3 weeks for a maximum of 6 courses
Arm II Patients receive docetaxel IV weekly for 6 weeks Treatment continues every 8 weeks for a maximum of 2 courses
Quality of life is assessed at baseline and days 22 and 43-56 for arm I and at baseline and days 22 and 43 for arm II
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20103 | None | None | None |
| ITA-INTN-DISTAL | None | None | None |