Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach
NCT ID: NCT02358863
Last Updated: 2018-09-06
Study Results
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View full resultsBasic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2015-02-28
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Georgetown University
OTHER
Responsible Party
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Principal Investigators
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John Marshall, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown University
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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2013-0973
Identifier Type: -
Identifier Source: org_study_id
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