Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene

Phase 2

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00303927
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Primary Completion: 2007-09
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-18
• Last Update Posted: 2010-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

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)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain