Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075374
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2004-01-09
Brief Title:
Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Multicenter Randomized Phase II Study of Two Schedules of Taxotere Weekly Versus Every 3 Weeks in Elderly or Poor Performance ECOG PS 2 Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-01
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 such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which docetaxel regimen is more effective for non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of docetaxel in treating patients who have not previously received chemotherapy for unresectable stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of docetaxel in treating patients who have not previously received chemotherapy for unresectable stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the effects of two different schedules of docetaxel on the incidence of grade 3 and 4 toxic effects in older or poor performance chemotherapy-naïve patients with unresectable stage IIIB or IV non-small cell lung cancer
Secondary
Compare the overall survival of patients treated with these regimens
Compare the response rate in patients treated with these regimens
Compare the incidence of serious adverse events in patients treated with these regimens
Determine the quality of life of patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 2 courses during study treatment and then at study completion
Patients are followed at 1 month and then every 2-3 months thereafter
PROJECTED ACCRUAL A total of 210-230 patients 105-115 per treatment arm will be accrued for this study
Primary
Compare the effects of two different schedules of docetaxel on the incidence of grade 3 and 4 toxic effects in older or poor performance chemotherapy-naïve patients with unresectable stage IIIB or IV non-small cell lung cancer
Secondary
Compare the overall survival of patients treated with these regimens
Compare the response rate in patients treated with these regimens
Compare the incidence of serious adverse events in patients treated with these regimens
Determine the quality of life of patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 2 courses during study treatment and then at study completion
Patients are followed at 1 month and then every 2-3 months thereafter
PROJECTED ACCRUAL A total of 210-230 patients 105-115 per treatment 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 |
|---|---|---|---|
| MTSMC-LUN06 | None | None | None |
| CWRU-MSMC-1503 | None | None | None |
| AVENTIS-GIA-12143 | None | None | None |
| THERADEX-GIA-12143 | None | None | None |