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

A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma

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.

Study Overview

• Status: Terminated
• Conditions: Gastric Cancer; Esophageal Cancer
• Intervention / Treatment: Drug: Modified FOLFOX6; Drug: Docetaxel/Capecitabine; Drug: Cisplatin/Irinotecan; Drug: Cisplatin/Docetaxel; Drug: IRI/EPI; Drug: EPI/Docetaxel; Drug: Irinotecan/Docetaxel; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Chemotherapy; 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

Drug: Modified FOLFOX6; Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1; Other Names: 5-FU; Eloxatin; Leucovorin; Oxaliplatin; 5-Flourouracil; Drug: Docetaxel/Capecitabine; Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14; Other Names: Taxotere; Xeloda; Drug: Cisplatin/Irinotecan; Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days; Other Names: Platinum; Camptosar; CPT-11; Drug: Cisplatin/Docetaxel; Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1; Other Names: Taxotere; Platinum; Drug: IRI/EPI; Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days; Other Names: Irinotecan; Camptosar; CPT-11; Epirubicin; Drug: EPI/Docetaxel; Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2; Other Names: Taxotere; Epirubicin; Drug: Irinotecan/Docetaxel; Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1; Other Names: Taxotere; Camptosar; CPT-11; Drug: Docetaxel; Docetaxel 60-100 mg/m2 IV day 1 every 21 days; Other Names: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patients With Tumor Size Reduction (Objective Response Rate)	Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.	1 year

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: John Marshall, MD, Georgetown University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Micronutrients; Antibiotics, Antineoplastic; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Docetaxel; Cisplatin; Capecitabine; Epirubicin; Oxaliplatin; Leucovorin; Irinotecan
• Other Study ID Numbers: 2013-0973