Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia

Conditions

• Metastatic Adenocarcinoma of Gastric Cardia
• Metastatic Adenocarcinoma of the Esophagus
• Unresectable Adenocarcinoma of Gastric Cardia
• Unresectable Adenocarcinoma of the Esophagus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FOLFOX — DRUG
  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
• 5-FU — DRUG
  5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.
• Erlotinib — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jan 11, 2008

Start date

Dec 31, 2007

Status verified

Feb 2016

Primary completion

Jun 30, 2011

Completion

Sep 30, 2015

Study Design

Enrollment

38 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: FOLFOX, plus 5-FU and Erlotinib
  single arm

Primary Outcome Measure

Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib. [ Time Frame: 3.5 years ]

Locations (2)

Find similar trials in Los Angeles, CA