Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054197
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2003-02-05
Brief Title:
Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS 2 Patients With Chemotherapy Naive Advanced 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 Combining more than one drug may kill more tumor cells It is not yet known whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of gemcitabine or vinorelbine in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of gemcitabine or vinorelbine in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of polyglutamate paclitaxel CT-2103 vs gemcitabine or vinorelbine in terms of duration of overall survival in patients with stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status of 2
Compare the safety of these regimens in these patients
Compare the disease control percentage of patients with no disease progression for at least 12 weeks and time to progression in patients treated with these regimens
Compare the response rate in patients with measurable disease treated with these regimens
Compare the improvement in lung cancer symptoms in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to gender disease stage IV vs other geographic location US vs Western Europe and Canada vs the rest of the world and prior brain metastases 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 every 21 days
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 every 28 days OR vinorelbine IV over 6-10 minutes on days 1 8 and 15 every 21 days
Treatment repeats in both arms for up to 6 courses 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 370 patients 185 per treatment arm will be accrued for this study within 13 months
Compare the efficacy of polyglutamate paclitaxel CT-2103 vs gemcitabine or vinorelbine in terms of duration of overall survival in patients with stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status of 2
Compare the safety of these regimens in these patients
Compare the disease control percentage of patients with no disease progression for at least 12 weeks and time to progression in patients treated with these regimens
Compare the response rate in patients with measurable disease treated with these regimens
Compare the improvement in lung cancer symptoms in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to gender disease stage IV vs other geographic location US vs Western Europe and Canada vs the rest of the world and prior brain metastases 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 every 21 days
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 every 28 days OR vinorelbine IV over 6-10 minutes on days 1 8 and 15 every 21 days
Treatment repeats in both arms for up to 6 courses 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 370 patients 185 per treatment arm will be accrued for this study within 13 months
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 |
|---|---|---|---|
| CDR0000269908 | REGISTRY | PDQ Physician Data Query | None |