Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well capecitabine works as second-line therapy in treating patients with stage IV pancreatic cancer who have the thymidylate synthase gene.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thymidylate Synthase (TS) Genotype-Directed Phase II Trial of Oral Capecitabine for 2-Line Treatment of Advanced Pancreatic Cancer|
- Survival at 6-months [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Association between capecitabine exposure at steady-state, allelic variants in candidate genes, and drug response [ Designated as safety issue: No ]
- Relationship between expression of TS, TP and DPD in tumor tissues and response [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
- 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 patient population.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303927
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Study Chair:||Wells Messersmith, MD||Sidney Kimmel Comprehensive Cancer Center|