Conditions: Unresectable Adenocarcinoma of the Esophagus Metastatic Adenocarcinoma of the Esophagus Unresectable Adenocarcinoma of Gastric Cardia Metastatic Adenocarcinoma of Gastric Cardia
Keywords: Unresectable Metastatic Esophagus Gastric Cardia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

Brief summary:
In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.

Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.

Detailed description:

Arms:
arm 1: single arm

Interventions: intervention 1: FOLFOX intervention 2: 5-FU intervention 3: Erlotinib
Intervention descriptions: intervention 1: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions intervention 2: 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. intervention 3: All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.

Protocol document: