Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054184
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2003-02-05
Brief Title:
Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer NSCLC A Phase III Study
Status:
TERMINATED
Status Verified Date:
2020-10
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 It is not yet known whether polyglutamate paclitaxel is more effective than docetaxel in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of docetaxel in treating patients who have progressive non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of docetaxel in treating patients who have progressive non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of polyglutamate paclitaxel CT-2103 vs docetaxel as second-line therapy in terms of duration of overall survival in patients with progressive non-small cell lung cancer
Compare the safety and toxicity of these regimens in these patients
Compare the disease control stable disease maintained for at least 12 weeks partial response or complete response and progression-free survival of patients treated with these regimens
Compare the improvement in lung cancer symptoms in patients treated with these regimens
Compare the frequency of grade 3 and 4 neurotoxicity edema alopecia and side effects related to corticosteroids in patients treated with these regimens
Determine the percentage of patients who receive at least 4 courses of study treatment
Compare the response rate in patients with measurable disease treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to stage IV vs other performance status 0 or 1 vs 2 start of front-line chemotherapy from randomization less than 16 weeks vs at least 16 weeks gender and prior taxane therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive polyglutamate paclitaxel CT-2103 IV over 10 minutes on day 1
Arm II Patients receive docetaxel IV over 1 hour on day 1 In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 840 patients 420 per treatment arm will be accrued for this study within 18 months
Compare the efficacy of polyglutamate paclitaxel CT-2103 vs docetaxel as second-line therapy in terms of duration of overall survival in patients with progressive non-small cell lung cancer
Compare the safety and toxicity of these regimens in these patients
Compare the disease control stable disease maintained for at least 12 weeks partial response or complete response and progression-free survival of patients treated with these regimens
Compare the improvement in lung cancer symptoms in patients treated with these regimens
Compare the frequency of grade 3 and 4 neurotoxicity edema alopecia and side effects related to corticosteroids in patients treated with these regimens
Determine the percentage of patients who receive at least 4 courses of study treatment
Compare the response rate in patients with measurable disease treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to stage IV vs other performance status 0 or 1 vs 2 start of front-line chemotherapy from randomization less than 16 weeks vs at least 16 weeks gender and prior taxane therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive polyglutamate paclitaxel CT-2103 IV over 10 minutes on day 1
Arm II Patients receive docetaxel IV over 1 hour on day 1 In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 840 patients 420 per treatment arm will be accrued for this study within 18 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 |
|---|---|---|---|
| CWRU-CTI-1503 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000269907 | REGISTRY | None | None |