Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049088
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2002-11-12
Brief Title:
Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of PS-341 in Combination With Docetaxel in Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
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 docetaxel in treating patients who have advanced solid tumors Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining bortezomib with docetaxel may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of bortezomib and docetaxel in patients with advanced solid tumors
II Determine the toxicity and tolerability of this regimen in these patients III Determine the biologic correlates of proteasome inhibition of bortezomib and determine the effects of this inhibition on the pharmacokinetics of docetaxel in these patients
IV Determine the antitumor efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study
For course 1 patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12 Patients then receive 1 week of rest For course 2 and all subsequent courses patients receive docetaxel on days 1 and 8 and bortezomib on days 2 5 9 and 12 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL A minimum of 24 patients will be accrued for this study
I Determine the maximum tolerated dose of bortezomib and docetaxel in patients with advanced solid tumors
II Determine the toxicity and tolerability of this regimen in these patients III Determine the biologic correlates of proteasome inhibition of bortezomib and determine the effects of this inhibition on the pharmacokinetics of docetaxel in these patients
IV Determine the antitumor efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study
For course 1 patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12 Patients then receive 1 week of rest For course 2 and all subsequent courses patients receive docetaxel on days 1 and 8 and bortezomib on days 2 5 9 and 12 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL A minimum of 24 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 |
|---|---|---|---|
| J0203 | None | None | None |
| U01CA070095 | NIH | None | None |
| CDR0000257807 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA070095 |