NCT02296671

Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study the investigators aim to: 1) confirm the objective response rate (ORR) observed in the investigators initial study for patients with the TSER\*2/\*2 genotype 2) determine whether PEMOX regimen is more worthy of future development for this patient genotype selected population than FOLFOX based on the data indicating that pemetrexed may be a better TS targeted agent than 5-FU. Patients who are homozygous for the TSER\*2 allele (TSER\*2/\*2) will be able to continue in the study and will be randomized. Patients with other TSER genotypes will not be included and will be considered screen fails. The first 8 patients with the TSER\*2/\*2 genotype will be randomized 1:1 to receive treatment with either PEMOX or FOLFOX (4 in each group). Analysis of the objective response rate (ORR) in each treatment arm will occur after the first 8 patients are enrolled. Using the proposed Bayesian design, subsequent patients will be preferentially assigned to the "better performing" treatment arm based on continuous real-time reassessments of ORR results.

Conditions

• Esophagogastric Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed
DRUG	Oxaliplatin
DRUG	Leucovorin
DRUG	Fluorouracil
GENETIC	Germline genotyping analyses for TSER

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-09-01
• Completion: 2022-02-01
• First posted: 2014-11-20
• Last updated: 2016-03-08