NCT01715233

Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.

A Phase II Study Investigating CHFR Methylation Status As A Biomarker For Taxane Sensitivity Using Modified Docetaxel, Cisplatin and 5 Fluorouracil In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR.

Detailed description

To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR. The overall response rates in the un-methylated and methylated patient groups will be reported with a exact 95% binomial confidence interval. A chi-square test will be used for comparison.

Conditions

• Metastatic Esophageal Cancer
• Gastroesophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Modified Docetaxel 40mg/m2 on Day 1
DRUG	Leucovorin	Leucovorin 400mg/m2 on Day 1
DRUG	Fluorouracil	Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2
DRUG	Cisplatin	Cisplatin (or Carboplatin) 40mg/m2 on Day 3

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-06-01
• Completion: 2017-04-01
• First posted: 2012-10-26
• Last updated: 2019-03-15
• Results posted: 2019-03-15

Locations

1 site across 1 country: United States