Thymidylate Synthase (TS) Genotype-Directed Phase II Trial of Oral Capecitabine for 2-Line Treatment of Advanced Pancreatic Cancer
- Characterize the 6-month survival of patients with stage IV pancreatic cancer
(progressing after at least 1 prior gemcitabine-containing chemotherapy regimen) who
carry the double tandem repeat (S/S) variant of the thymidylate synthase (TS) gene
enhancer region (TSER) treated with capecitabine.
- Characterize toxicity of capecitabine in patients with stage IV pancreatic cancer who
carry the S/S variant of the TSER.
- Explore the association between capecitabine exposure at steady-state, allelic variants
in candidate genes (carboxylesterase 1, carboxylesterase 2, cytidine deaminase,
thymidine phosphorylase [TP], dihydropyrimidine dehydrogenase [DPD],
methylenetetrahydrofolate reductase) and drug response (toxicity and efficacy) in this
- Determine the relationship between expression of TS, TP, and DPD in tumor tissues and
the response to capecitabine in this patient population.
- Analyze response rate to capecitabine, based on the presence of homozygous S/S variant
of the TSER.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Survival at 6-months
Wells Messersmith, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|