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

Georgetown University

Status

Terminated

Conditions

Gastric Cancer

Esophageal Cancer

Treatments

Drug: Cisplatin/Docetaxel

Drug: Irinotecan/Docetaxel

Drug: Modified FOLFOX6

Drug: Docetaxel

Drug: IRI/EPI

Drug: EPI/Docetaxel

Drug: Cisplatin/Irinotecan

Drug: Docetaxel/Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT02358863

2013-0973

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Chemotherapy

Experimental group

Description:

Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel

Treatment: