Phase I Study of Lapatinib (GW572016) in Combination With Weekly Ixabepilone (BMS 247550) in Advanced Solid Tumors
- To evaluate the safety and feasibility of lapatinib ditosylate in combination with
ixabepilone in patients with advanced solid tumors.
- 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Toxicity
Assessed by NCI CTCAE v 3.0
Toxicity will be assessed at the beginning of every cycle and on day 8 and 15 of every cycle for at least eight weeks (2 cycles). Maximum of 6 cycles.
Helen K. Chew, MD
University of California, Davis
United States: Food and Drug Administration
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences||Shreveport, Louisiana 71130-3932|