Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068484
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2003-09-10
Brief Title:
A Dose Finding Phase I Trial of the Combination of Topotecan and PS-341 a Novel Proteasome Inhibitor in Advanced Malignancies
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose Finding Phase I Trial of the Combination of Topotecan and PS-341 a Novel Proteasome Inhibitor in Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy such as topotecan use different ways to stop tumor cells from dividing so they stop growing or die Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Combining topotecan with bortezomib may kill more tumor cells This phase I trial is studying the side effects and best dose of topotecan and bortezomib when given together in treating patients with metastatic or unresectable cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety of the combination of PS-341 and topotecan II Determine the dose limiting toxicities and maximum tolerated dose as well as the recommended phase II doses of the combination
III Assess the pharmacokinetics of topotecan alone and in combination with PS-341
SECONDARY OBJECTIVES
I Estimate the objective response rate of a combination of PS-341 and topotecan delivered on days 1-5 every three weeks as defined by the RECIST criteria
II Assess the pharmacodynamics of topo I levels III Determine the expression of the DNA repair enzyme XRCC1 in tumor biopsies
OUTLINE This is a dose-escalation study
Patients receive topotecan IV over 30 minutes on days 1-5 Beginning with course 2 patients also receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan and bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for this study
I Determine the safety of the combination of PS-341 and topotecan II Determine the dose limiting toxicities and maximum tolerated dose as well as the recommended phase II doses of the combination
III Assess the pharmacokinetics of topotecan alone and in combination with PS-341
SECONDARY OBJECTIVES
I Estimate the objective response rate of a combination of PS-341 and topotecan delivered on days 1-5 every three weeks as defined by the RECIST criteria
II Assess the pharmacodynamics of topo I levels III Determine the expression of the DNA repair enzyme XRCC1 in tumor biopsies
OUTLINE This is a dose-escalation study
Patients receive topotecan IV over 30 minutes on days 1-5 Beginning with course 2 patients also receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan and bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 20-25 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 |
|---|---|---|---|
| CDR0000322889 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR21CA097750 |
| HIC 12760 | None | None | None |
| R21CA097750 | NIH | None | None |