Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030368
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-02-14
Brief Title:
Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of PS-341 in Combination With Paclitaxel in Metastatic Solid Tumors
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:
Phase I trial to study the effectiveness of combining bortezomib with paclitaxel in treating patients who have advanced or metastatic solid tumors Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Combining bortezomib with paclitaxel may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of bortezomib when given in combination with paclitaxel in patients with locally advanced or metastatic solid tumors
OUTLINE This is a multicenter dose-escalation study of bortezomib
Patients receive bortezomib IV on days 2 and 9 and paclitaxel IV over 1 hour on days 1 and 8 For the first course only patients do not receive paclitaxel on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity or greater than 80 20S proteasome inhibition Once the MTD is determined an additional 6-9 patients are accrued and treated at that dose
Patients are followed at 21 days
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
I Determine the maximum tolerated dose of bortezomib when given in combination with paclitaxel in patients with locally advanced or metastatic solid tumors
OUTLINE This is a multicenter dose-escalation study of bortezomib
Patients receive bortezomib IV on days 2 and 9 and paclitaxel IV over 1 hour on days 1 and 8 For the first course only patients do not receive paclitaxel on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity or greater than 80 20S proteasome inhibition Once the MTD is determined an additional 6-9 patients are accrued and treated at that dose
Patients are followed at 21 days
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| 0158 | None | None | None |
| NCI-1857 | None | None | None |
| CDR0000069159 | None | None | None |
| OSU-01H0147 | None | None | None |