Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene
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|ClinicalTrials.gov Identifier: NCT00303927|
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : March 19, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: capecitabine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Masking:||None (Open Label)|
|Official Title:||Thymidylate Synthase (TS) Genotype-Directed Phase II Trial of Oral Capecitabine for 2-Line Treatment of Advanced Pancreatic Cancer|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||September 2007|
- Survival at 6-months
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|