Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313599
Status:
COMPLETED
Last Update Posted:
2014-07-02
First Post:
2006-04-11
Brief Title:
Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase I Dose Escalation Study of a 2 Day Oral Lapatinib Chemosensitization Pulse Given Prior To Weekly Intravenous Abraxane in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-07
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 paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Lapatinib may help paclitaxel work better by making tumor cells more sensitive to the drug Lapatinib may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving lapatinib together with paclitaxel may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib when given together with paclitaxel in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib when given together with paclitaxel in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of a 2-day pulse of lapatinib that can be given prior to paclitaxel albumin-stabilized nanoparticle formulation ABI-007 Abraxane in patients with advanced solid tumor malignancies
Secondary
Define the toxicity of this regimen
Determine preliminarily the antitumor efficacy and safety of ABI-007 when preceded by a 2-day pulse of lapatinib
Characterize the potential of the molecular markers within circulating tumor cells as markers of response eg HER2 and AKT or apoptotic markers
Determine whether lapatinib given at MTD prior to ABI-007 alters the pharmacokinetic properties of the paclitaxel component of ABI-007
OUTLINE This is a does-escalation study of lapatinib Patients are stratified according to dose level
Patients receive oral lapatinib on days 1 2 8 9 15 and 16 and paclitaxel albumin-stabilized nanoparticle formulation ABI-007 Abraxane IV over 30 minutes on days 3 10 and 17 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of lapatinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicities
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD of a 2-day pulse of lapatinib that can be given prior to paclitaxel albumin-stabilized nanoparticle formulation ABI-007 Abraxane in patients with advanced solid tumor malignancies
Secondary
Define the toxicity of this regimen
Determine preliminarily the antitumor efficacy and safety of ABI-007 when preceded by a 2-day pulse of lapatinib
Characterize the potential of the molecular markers within circulating tumor cells as markers of response eg HER2 and AKT or apoptotic markers
Determine whether lapatinib given at MTD prior to ABI-007 alters the pharmacokinetic properties of the paclitaxel component of ABI-007
OUTLINE This is a does-escalation study of lapatinib Patients are stratified according to dose level
Patients receive oral lapatinib on days 1 2 8 9 15 and 16 and paclitaxel albumin-stabilized nanoparticle formulation ABI-007 Abraxane IV over 30 minutes on days 3 10 and 17 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of lapatinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicities
PROJECTED ACCRUAL A total of 15 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