Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080665
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2004-04-07
Brief Title:
Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I Study Of Weekly Taxotere Docetaxel And Gleevec STI571 Imatinib Mesylate CGP 57148B In Locally Advanced Or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-04
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:
RATIONALE Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving docetaxel with imatinib mesylate may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with imatinib mesylate in treating patients with locally advanced or metastatic breast cancer
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with imatinib mesylate in treating patients with locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety profile maximum tolerated dose and recommended phase II dose of docetaxel when administered with imatinib mesylate in patients with locally advanced or metastatic breast cancer
Secondary
Determine the pharmacokinetic profile of this regimen in these patients
Determine the potential effects of this regimen on CYP3A4 activity and docetaxel metabolism in these patients
Correlate docetaxel and imatinib mesylate exposure utilizing total and unbound docetaxel and imatinib mesylate plasma concentrations with drug response eg pharmacodynamic effects drug toxicity and response in these patients
Determine response rate duration of response and time to treatment failure in patients treated with this regimen
Correlate proteomic profile changes in serum with tumor burden and response in patients treated with this regimen
Correlate pharmacokinetic parameters tissue expression of specific receptor tyrosine kinases eg c-Kit platelet-derived growth factor receptor PDGFR and phosphorylated PDGFR in paraffin blocks and pharmacodynamic assays with antitumor activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of docetaxel
Patients receive docetaxel IV over 1 hour on days 1 8 and 15 and oral imatinib mesylate STI571 on days 8-28 of course 1 and days 1-28 of all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after at least 2 courses of therapy may discontinue docetaxel and continue therapy with single-agent STI571 until disease progression
NOTE Patients experiencing excessive docetaxel-related toxicity who have completed at least 2 full courses may continue on single-agent STI571 in the absence of disease progression or excessive STI571-related toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel 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 An additional cohort of 6-12 patients receives treatment at the MTD
Patients are followed at 30 days
PROJECTED ACCRUAL Approximately of 18-30 patients will be accrued for this study
Primary
Determine the safety profile maximum tolerated dose and recommended phase II dose of docetaxel when administered with imatinib mesylate in patients with locally advanced or metastatic breast cancer
Secondary
Determine the pharmacokinetic profile of this regimen in these patients
Determine the potential effects of this regimen on CYP3A4 activity and docetaxel metabolism in these patients
Correlate docetaxel and imatinib mesylate exposure utilizing total and unbound docetaxel and imatinib mesylate plasma concentrations with drug response eg pharmacodynamic effects drug toxicity and response in these patients
Determine response rate duration of response and time to treatment failure in patients treated with this regimen
Correlate proteomic profile changes in serum with tumor burden and response in patients treated with this regimen
Correlate pharmacokinetic parameters tissue expression of specific receptor tyrosine kinases eg c-Kit platelet-derived growth factor receptor PDGFR and phosphorylated PDGFR in paraffin blocks and pharmacodynamic assays with antitumor activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of docetaxel
Patients receive docetaxel IV over 1 hour on days 1 8 and 15 and oral imatinib mesylate STI571 on days 8-28 of course 1 and days 1-28 of all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after at least 2 courses of therapy may discontinue docetaxel and continue therapy with single-agent STI571 until disease progression
NOTE Patients experiencing excessive docetaxel-related toxicity who have completed at least 2 full courses may continue on single-agent STI571 in the absence of disease progression or excessive STI571-related toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel 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 An additional cohort of 6-12 patients receives treatment at the MTD
Patients are followed at 30 days
PROJECTED ACCRUAL Approximately of 18-30 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 |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-J0214 | OTHER | None | None |
| SKCCC-J0214 | OTHER | SKCCC at Johns Hopkins | httpsreporternihgovquickSearchP30CA006973 |