Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064012
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2003-07-08
Brief Title:
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Randomized Multicenter Open-Label Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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 such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the tumor response rates complete and partial response in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel
Secondary
Compare time to progression in patients treated with these regimens
Compare the overall and 1-year survival of patients treated with these regimens
Compare the safety and tolerability of these regimens in these patients
Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11
Arm II Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond confirmation of CR
Quality of life is assessed on day 1 of each treatment course before drug administration and at 30 days after the completion of study treatment
Patients are followed at 30 days and then every 3 months for survival
PROJECTED ACCRUAL A total of 155 patients 75 for arm I and 80 for arm II will be accrued for this study within 1 year
Primary
Compare the tumor response rates complete and partial response in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel
Secondary
Compare time to progression in patients treated with these regimens
Compare the overall and 1-year survival of patients treated with these regimens
Compare the safety and tolerability of these regimens in these patients
Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11
Arm II Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond confirmation of CR
Quality of life is assessed on day 1 of each treatment course before drug administration and at 30 days after the completion of study treatment
Patients are followed at 30 days and then every 3 months for survival
PROJECTED ACCRUAL A total of 155 patients 75 for arm I and 80 for arm II will be accrued for this study within 1 year
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 |
|---|---|---|---|
| MILLENNIUM-M34102-048 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016042 |
| P30CA016042 | NIH | None | None |
| WCCC-M34102-048 | None | None | None |
| UCLA-0301037 | None | None | None |