Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093756
Status:
COMPLETED
Last Update Posted:
2017-12-07
First Post:
2004-10-06
Brief Title:
Bortezomib Paclitaxel Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of PS-341 in Combination With Paclitaxel Carboplatin and Concurrent Thoracic Radiation Therapy for Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2017-11
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 phase III trial phase I closed to accrual as of 09292009 is studying the side effects and best dose of bortezomib paclitaxel and carboplatin when given with radiation therapy and to see how well they work in treating patients with stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Bortezomib may increase the effectiveness of paclitaxel and carboplatin by making tumor cells more sensitive to the drugs Radiation therapy uses high-energy x-rays to damage tumor cells Giving bortezomib paclitaxel and carboplatin together with radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of bortezomib paclitaxel and carboplatin when administered with fractionated radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer Phase I closed to accrual as of 09292009 II Determine the 1-year survival of patients treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the tolerability of this regimen in these patients Phase II II Determine the response rate progression-free survival and overall survival of patients treated with this regimen Phase II III Correlate p27 expression in tumor tissue with survival time to progression and response in patients treated with this regimen Phase II
OUTLINE This is a multicenter phase I closed to accrual as of 09292009 dose-escalation study of bortezomib paclitaxel and carboplatin followed by a phase II study
PHASE I closed to accrual as of 09292009 Patients receive bortezomib IV on days 1 4 8 and 11 Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 2 Patients undergo radiotherapy once daily on days 1-5 8-12 15-19 Treatment repeats every 3 weeks up to 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of bortezomib paclitaxel and carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive bortezomib paclitaxel and carboplatin as in phase I at the MTD Patients also undergo radiotherapy as in phase I Patients are followed up periodically for up to 5 years from the time of registration
I Determine the maximum tolerated dose of bortezomib paclitaxel and carboplatin when administered with fractionated radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer Phase I closed to accrual as of 09292009 II Determine the 1-year survival of patients treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the tolerability of this regimen in these patients Phase II II Determine the response rate progression-free survival and overall survival of patients treated with this regimen Phase II III Correlate p27 expression in tumor tissue with survival time to progression and response in patients treated with this regimen Phase II
OUTLINE This is a multicenter phase I closed to accrual as of 09292009 dose-escalation study of bortezomib paclitaxel and carboplatin followed by a phase II study
PHASE I closed to accrual as of 09292009 Patients receive bortezomib IV on days 1 4 8 and 11 Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 2 Patients undergo radiotherapy once daily on days 1-5 8-12 15-19 Treatment repeats every 3 weeks up to 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of bortezomib paclitaxel and carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive bortezomib paclitaxel and carboplatin as in phase I at the MTD Patients also undergo radiotherapy as in phase I Patients are followed up periodically for up to 5 years from the time of registration
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 |
|---|---|---|---|
| NCI-2009-00643 | REGISTRY | None | None |
| CDR0000390108 | None | None | None |
| NCCTG-N0321 | None | None | None |
| N0321 | OTHER | None | None |
| N0321 | OTHER | None | None |
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |