22
Participants
Start Date
December 31, 2005
Primary Completion Date
April 30, 2009
Study Completion Date
December 31, 2011
lapatinib ditosylate
Given orally for 28 days per dose level (Dose level 1: 250mg; Dose level 2: 500mg; Dose level 3: 1000mg; Dose level 4: 1250mg; Dose level 5: 1500mg; Dose level 6: 1500mg)
vinorelbine ditartrate
Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 20mg/m2; Dose level 4: 20mg/m2; Dose level 5: 20mg/m2; Dose level 6: 25mg/m2)
comparative genomic hybridization
Molecular correlative study
cytogenetic analysis
Molecular correlative study
gene expression analysis
Molecular correlative study
mutation analysis
Molecular correlative study
polymerase chain reaction
Molecular correlative study
polymorphism analysis
Molecular correlative study
proteomic profiling
Molecular correlative study
reverse transcriptase-polymerase chain reaction
Molecular correlative study
immunohistochemistry staining method
Molecular correlative study
laboratory biomarker analysis
Molecular correlative study
lapatinib ditosylate
Given orally on Days 2-5, 9-12 and 16-25 per dose level (Dose level 1: 1250mg; Dose level 2: 1500mg; Dose level 3: 1500mg; Dose level 4: 1700mg)
Vinorelbine ditartrate
Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 25mg/m2; Dose level 4: 25mg/m2)
University of California Davis Cancer Center, Sacramento
City of Hope Comprehensive Cancer Center, Duarte
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles
Seattle Cancer Care Alliance, Seattle
National Cancer Institute (NCI)
NIH
University of California, Davis
OTHER