This phase II trial is studying how well selumetinib works in treating patients with biliary cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Name: selumetinib
Name: laboratory biomarker analysis
Description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measure: Objective Response Rate (CR and PR) Time: Every 8 weeksDescription: Toxicitity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Measure: Toxicity Profile of AZD6244 Time: From the time of first treatment with AZD6244, assessed up to 4 weeksDescription: Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measure: Median Progression Free Survival for Patients Time: Up to 6 monthsDescription: Measure the proteins levels of RAS/RAF/MEK/ERK signaling pathway activation to AZD6244
Measure: Protein Levels of RAS/RAF/MEK/ERK Signaling Pathway Activation Time: At baselineAllocation: N/A
Single Group Assignment
There is one SNP
To genotype tumors for the presence of RAS mutations (i.e., NRAS, KRAS, HRAS) and BRAF mutations (e.g., V600E) in biliary tumor samples from these patients. --- V600E ---