Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118183
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2005-07-08
Brief Title:
Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Docetaxel Plus Cetuximab and Docetaxel Plus Bortezomib NSC 681239 IND 58443 in Advanced Non-Small Cell Lung Cancer Patients With Performance Status PS 2
Status:
COMPLETED
Status Verified Date:
2013-06
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 randomized phase II trial is studying how well giving docetaxel together with either cetuximab or bortezomib works as first-line therapy in treating patients with stage III or stage IV 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 Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving docetaxel together with either cetuximab or bortezomib may be effective as first-line therapy in treating non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the progression free survival PFS defined as the time between study entry and disease progression or death for each of the two combination regimens
SECONDARY OBJECTIVES
I To determine the overall response rate of each regimen II To evaluate the overall survival distributions associated with each regimen
III To evaluate the toxicities of each regimen
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 and cetuximab IV over 1-2 hours on days 1 8 15 and 22 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease after 4 courses receive cetuximab alone as above 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 1 8 and 15 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease after 4 courses receive bortezomib alone as above in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed monthly for 1 year every 2 months for 2 years and then every 4 months for 3 years
PROJECTED ACCRUAL A total of 62 patients 31 per treatment arm will be accrued for this study within 6-11 months
I To evaluate the progression free survival PFS defined as the time between study entry and disease progression or death for each of the two combination regimens
SECONDARY OBJECTIVES
I To determine the overall response rate of each regimen II To evaluate the overall survival distributions associated with each regimen
III To evaluate the toxicities of each regimen
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 and cetuximab IV over 1-2 hours on days 1 8 15 and 22 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease after 4 courses receive cetuximab alone as above 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 1 8 and 15 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease after 4 courses receive bortezomib alone as above in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed monthly for 1 year every 2 months for 2 years and then every 4 months for 3 years
PROJECTED ACCRUAL A total of 62 patients 31 per treatment arm will be accrued for this study within 6-11 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 |
|---|---|---|---|
| CALGB-30402 | None | None | None |
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |