Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362882
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2006-08-10
Brief Title:
Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial of Sequential Versus Concurrent Docetaxel and PS-341 NSC 681239 in Previously Treated Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2017-10
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:
This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving docetaxel together with bortezomib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVE
I To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated progressive or recurrent advanced non-small cell lung cancer NSCLC
SECOND OBJECTIVES
I To compare time to progression in patients with previously treated NSCLC treated with these regimens
II To compare 1-year and overall survival of patients treated with these regimens
III To compare the toxicity of these regimens in these patients IV To determine the pharmacokinetics of docetaxel in the context of this study
TERTIARY OBJECTIVE
I To determine levels of expression of molecular markers regulated by docetaxel and bortezomib and correlate with clinical response and overall survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOG performance status 0 vs 1 and number of prior chemotherapy treatments 1 vs 1 Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically
I To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated progressive or recurrent advanced non-small cell lung cancer NSCLC
SECOND OBJECTIVES
I To compare time to progression in patients with previously treated NSCLC treated with these regimens
II To compare 1-year and overall survival of patients treated with these regimens
III To compare the toxicity of these regimens in these patients IV To determine the pharmacokinetics of docetaxel in the context of this study
TERTIARY OBJECTIVE
I To determine levels of expression of molecular markers regulated by docetaxel and bortezomib and correlate with clinical response and overall survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOG performance status 0 vs 1 and number of prior chemotherapy treatments 1 vs 1 Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically
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 |
|---|---|---|---|
| PHII-70 | None | None | None |
| N01CM17101 | NIH | None | None |
| CDR0000491470 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17101 |