Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039455
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2002-06-06
Brief Title:
Trastuzumab and Flavopiridol in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of HerceptinFlavopiridol in HER-2 Positive Metastatic Breast Cancer
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:
Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining trastuzumab with flavopiridol may kill more tumor cells Phase I trial to study the effectiveness of combining trastuzumab with flavopiridol in treating patients who have metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and tolerability of flavopiridol in combination with Herceptin in HER-2 positive metastatic breast cancer
SECONDARY OBJECTIVES
I To determine the dose of flavopiridol necessary to achieve a target plasma level of 300-500 nM of flavopiridol in combination with a fixed dose of Herceptin
II To assess the feasibility of measuring cyclin D1 in circulating tumor cells and tissue biopsies before and after therapy as a surrogate marker of flavopiridol activity
III To monitor target activity of flavopiridol and Herceptin in plasma circulating tumor cells and tissue biopsies from breast cancer patients
OUTLINE This is a multicenter dose-escalation study of flavopiridol
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 followed by flavopiridol IV continuously over 24 hours on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose is determined MTD The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of 10 patients receives flavopiridol at the MTD and trastuzumab on the once weekly schedule to assess the true toxicity rate A second cohort of 10 patients receives flavopiridol at the MTD and trastuzumab once every 21 days to assess the tolerability of this schedule
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study
I To evaluate the safety and tolerability of flavopiridol in combination with Herceptin in HER-2 positive metastatic breast cancer
SECONDARY OBJECTIVES
I To determine the dose of flavopiridol necessary to achieve a target plasma level of 300-500 nM of flavopiridol in combination with a fixed dose of Herceptin
II To assess the feasibility of measuring cyclin D1 in circulating tumor cells and tissue biopsies before and after therapy as a surrogate marker of flavopiridol activity
III To monitor target activity of flavopiridol and Herceptin in plasma circulating tumor cells and tissue biopsies from breast cancer patients
OUTLINE This is a multicenter dose-escalation study of flavopiridol
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 followed by flavopiridol IV continuously over 24 hours on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose is determined MTD The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of 10 patients receives flavopiridol at the MTD and trastuzumab on the once weekly schedule to assess the true toxicity rate A second cohort of 10 patients receives flavopiridol at the MTD and trastuzumab once every 21 days to assess the tolerability of this schedule
PROJECTED ACCRUAL A total of 30-50 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 |
|---|---|---|---|
| CDR0000069385 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchP50CA089393 |
| 01-177 | None | None | None |
| P50CA089393 | NIH | None | None |