Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors

Completed · Phase 2

Conditions studied: Stomach Neoplasms, Esophageal Neoplasms

In brief

This study is for patients who have stomach cancer or cancer of the lower part of the esophagus that has spread to other organs. There are many different chemotherapy treatments for this type of cancer. At the present time, there is no general agreement on the way to choose the most beneficial therapy for an individual patient. Patients with different genetic backgrounds may respond differently to the same chemotherapy treatments. In this study the investigators will use a certain genetic difference in an important gene (thymidylate synthase or TS gene) to see whether treating patients who have a particular type of that gene will respond better to a standard chemotherapy regimen. The investigators are hoping that by treating patients according to their genes, that they may respond to treatment of their cancer better and it will help the investigators choose cancer treatments better in the future.

Key facts

Study ID

NCT00515216

Run by

Vanderbilt University

People needed

26

Starts

2007-08-01

Expected to finish

2013-11-01

Last updated by the study team

2016-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
• Patients must have measurable disease.
• No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is permitted if the disease free interval has been longer than 6 months.
• Age ≥18 years.
• Life expectancy of greater than 3 months.
• ECOG (Eastern Cooperative Oncology Group) performance status greater than 2 (Karnofsky greater than 60%).
• Patients must have normal organ and marrow function.
• Not pregnant. Not breast feeding.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Patients may not be receiving any other chemotherapy agents.
• Patients with known active brain metastases. Patients with treated brain metastases are permitted if stable off steroids for at least 30 days.
• History of allergic reactions to 5-FU or oxaliplatin.
• Uncontrolled intercurrent illness.
• Patients with immune deficiency.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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