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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborators: National Cancer Institute (NCI); University of Alabama at Birmingham; University of North Carolina; Washington University School of Medicine
• Treatments: Fluorouracil; Formyltetrahydrofolates; Leucovorin; Levoleucovorin; Oxaliplatin; Tetrahydrofolates

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.