A Phase II Study Investigating CHFR Methylation Status As A Biomarker For Taxane Sensitivity Using Modified Docetaxel, Cisplatin and 5 Flourouracil In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.
Johns Hopkins Bayview Medical Center
Johns Hopkins Kimmel Cancer Center in Baltimore
To determine the objective response rate of modified DCF (Docetaxel/Cisplatin/5Flourouracil), when methylation of CHFR is used as a biomarker to decide if a taxane based regimen is administered.
-metastatic or locally recurrent disease of the esophagus, gastroesophageal junction or stomach -no prior chemotherapy for metastatic or locally recurrent disease, prior radiation allowed -measurable disease -good physical condition with good blood counts and organ function -no chemotherapy or radiation within 4 weeks of starting -brain metastases are not allowed -certain medications may be prohibited while on study -no uncontrolled medical conditions -HIV positive patients on antiretroviral therapy are not eligible
Patients who are referred for chemotherapy for metastatic esophageal, gastro-esophageal or gastric cancer will be presented with the option for enrollment in this study. After signing a pre-screening consent form, patients will have their tumor tissue analyzed for CHFR methylation. Patients with CHFR methylation will be enrolled on study and will receive the combination of Docetaxel, Cisplatin, and 5 Flourouracil. Patients without CHFR methylation will not be treated on study but will be offered standard of care therapy or an alternative clinical trial. Each cycle of treatment is 14 days and a maximun of 8 cycles (4 months) are allowed.
07/05/2015 04:01 AM