Conditions: Neoplasms, Colorectal
Keywords: Metastatic Colorectal Cancer oxaliplatin fluoropyrimidines cancers Advanced Colorectal Cancer capecitabine lapatinib
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.

Detailed description:

Arms:
arm 1: Dose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached. arm 2: Treatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin

Interventions: intervention 1: lapatinib intervention 2: oxaliplatin intervention 3: capecitabine
Intervention descriptions: intervention 1: onced daily Days 1-21 intervention 2: Day one of each cycle intervention 3: given BID days 1-14

Protocol document: