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

Gastric Cancer Clinical Trial

— mEGA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02358863
• Other study ID #: 2013-0973
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

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
• Docetaxel/Capecitabine
Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14
• 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
• Cisplatin/Docetaxel
Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1
• 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
• EPI/Docetaxel
Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2
• Irinotecan/Docetaxel
Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1
• Docetaxel
Docetaxel 60-100 mg/m2 IV day 1 every 21 days

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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