Breast Cancer Clinical Trial
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
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.
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 (e.g., 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.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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