Viewing Study NCT00084513



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Study NCT ID: NCT00084513
Status: COMPLETED
Last Update Posted: 2010-02-12
First Post: 2004-06-10

Brief Title: Trastuzumab and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic HER2Neu-Expressing Cancer
Sponsor: Fox Chase Cancer Center
Organization: Fox Chase Cancer Center

Study Overview

Official Title: Phase I of Trastuzumab and Imatinib Mesylate Gleevec Formerly Known as STI-571 in Patients With Recurrent or Metastatic Her-2Neu Expressing Cancer
Status: COMPLETED
Status Verified Date: 2010-02
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 Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor Giving trastuzumab together with imatinib mesylate may kill more tumor cells

PURPOSE This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with trastuzumab in treating patients with recurrent or metastatic HER2neu-expressing producing cancer
Detailed Description: OBJECTIVES

Primary

Determine the maximum tolerated dose of imatinib mesylate when administered with trastuzumab Herceptin in patients with recurrent or metastatic HER2neu-overexpressing cancer
Determine response in patients treated with this regimen

Secondary

Correlate the number of circulating tumor cells with radiographic imaging in patients treated with this regimen

OUTLINE This is a dose-escalation study of imatinib mesylate

Patients receive trastuzumab Herceptin IV over 90 minutes on day 1 and oral imatinib mesylate once or twice daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity

Cohorts of 3-6 patients receive escalating doses of imatinib mesylate 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

PROJECTED ACCRUAL Approximately 9-18 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
P30CA006927 NIH None None
FCCC-03041 None None None
NOVARTIS-FCCC-03041 US NIH GrantContract None httpsreporternihgovquickSearchP30CA006927