Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014430
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2001-04-10
Brief Title:
Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Phase I Clinical Trial Of Vinorelbine Navelbine And Trastuzumab Herceptin In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2NEU Overexpression
Status:
COMPLETED
Status Verified Date:
2002-11
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 use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or metastatic breast cancer
PURPOSE Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of vinorelbine in combination with trastuzumab Herceptin in patients with HER-2neu overexpressing unresectable or metastatic non-small cell lung cancer closed to accrual as of 41601 or refractory locally advanced or metastatic breast cancer
Determine the pharmacokinetic and pharmacodynamic profiles of this regimen in this patient population
Determine the objective response rate of patients treated with this regimen
OUTLINE This is a dose-escalation study of vinorelbine
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and trastuzumab Herceptin IV over 30-90 minutes on days 8 and 15 of course 1 and days 1 8 and 15 of all subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3 to 6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 30-35 patients will be accrued for this study
Determine the maximum tolerated dose of vinorelbine in combination with trastuzumab Herceptin in patients with HER-2neu overexpressing unresectable or metastatic non-small cell lung cancer closed to accrual as of 41601 or refractory locally advanced or metastatic breast cancer
Determine the pharmacokinetic and pharmacodynamic profiles of this regimen in this patient population
Determine the objective response rate of patients treated with this regimen
OUTLINE This is a dose-escalation study of vinorelbine
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and trastuzumab Herceptin IV over 30-90 minutes on days 8 and 15 of course 1 and days 1 8 and 15 of all subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3 to 6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 30-35 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 |
|---|---|---|---|
| NCI-G01-1932 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023108 |
| P30CA023108 | NIH | None | None |
| DMS-9904 | None | None | None |