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Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers

NCT02296671 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-03-08

No results posted yet for this study

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

DRUG

Pemetrexed

DRUG

Oxaliplatin

DRUG

Leucovorin

DRUG

Fluorouracil

GENETIC

Germline genotyping analyses for TSER

Sponsors & Collaborators

  • Gateway for Cancer Research

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • A. Craig Lockhart, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-09-30
Completion
2022-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02296671 on ClinicalTrials.gov