Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017407
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2001-06-06
Brief Title:
Carboplatin and Paclitaxel With or Without ISIS 3521 in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
Official Title:
A Prospective Randomized Open-label Phase III Trial of Chemotherapy With Carboplatin And Paclitaxel Versus Carboplatin And Paclitaxel In Combination With ISIS-3521 An Antisense Inhibitor Of Protein Kinase C Alpha In Patients With Advanced Previously Untreated Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2006-12
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 ISIS 3521 may help kill more cancer cells by making tumor cells more sensitive to chemotherapy It is not yet known if carboplatin and paclitaxel are more effective with or without ISIS 3521
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel with or without ISIS 3521 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 carboplatin and paclitaxel with or without ISIS 3521 in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the overall survival of patients with stage IIIB or IV non-small cell lung cancer treated with carboplatin and paclitaxel with vs without ISIS 3521 II Compare the time to tumor progression and time to treatment failure in patients treated with these regimens III Compare the overall complete plus partial response rate in patients with measurable disease treated with these regimens IV Compare the percentage of patients with non-measurable evaluable disease who have a complete response after treatment with these regimens V Compare the duration of response in patients with a complete or partial response after treatment with these regimens VI Compare the safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor stage IIIB vs IV and prior brain metastases yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 0 Arm II Patients receive ISIS 3521 IV continuously on days 0-14 and paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 3 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease receive 6 courses of treatment Patients with responsive disease may receive additional courses of treatment Patients are followed at 1 2 4 and 6 months and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 600 patients 300 per treatment arm will be accrued for this study within 15 months
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor stage IIIB vs IV and prior brain metastases yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 0 Arm II Patients receive ISIS 3521 IV continuously on days 0-14 and paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 3 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease receive 6 courses of treatment Patients with responsive disease may receive additional courses of treatment Patients are followed at 1 2 4 and 6 months and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 600 patients 300 per treatment arm will be accrued for this study within 15 months
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 |
|---|---|---|---|
| ISIS-1501 | None | None | None |
| ISIS-3521-CS17 | None | None | None |
| CWRU-040123 | None | None | None |