Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Treatments: Camptothecin; Capecitabine; Cisplatin; Docetaxel; Epirubicin; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria

• Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)

• Patients who are not eligible for resection and are chemotherapy naïve

• Patients with HER2(-) status

• Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance

• Patients must have adequate organ function

• Patients must provide written informed consent

Exclusion Criteria:

• Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years

• ECOG performance status worse than 2

• Prior oral or intravenous chemotherapy for metastatic disease

• Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen

• cardiac ejection fraction 45% or greater