Lapatinib and Ixabepilone in Treating Patients With Advanced Solid Tumors

OBJECTIVES:

Primary

- To evaluate the safety and feasibility of lapatinib ditosylate in combination with
ixabepilone in patients with advanced solid tumors.

Secondary

- To determine the maximum-tolerated dose of this regimen in these patients.

- To assess, preliminarily, the efficacy of this regimen in these patients.

- To perform laboratory correlative studies on tissue and blood specimens from these
patients to investigate potential predictors of response.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive oral lapatinib ditosylate once daily on days 1-28 and ixabepilone IV on
days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

Archival tumor tissue samples are collected for EGFR/HER2 pathway analyses via
immunohistochemistry, mRNA analysis via RT-PCR, EGFR mutation analyses, Kras and braf
mutation analysis via sequencing, and RAS mutations via PCR and sequencing. Blood samples
are also collected periodically for tumor DNA and proteomics, acetylated alpha-tubulin
analysis, EGFR-HER2 pathway genotypes, and pharmacogenomics.

After completion of study therapy, patients are followed for 30 days.