Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00303927
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival at 6-months Toxicity
- Secondary Outcome Measures
Name Time Method Association between capecitabine exposure at steady-state, allelic variants in candidate genes, and drug response Relationship between expression of TS, TP and DPD in tumor tissues and response Response rate
Trial Locations
- Locations (2)
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States