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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02358863
Recruitment Status : Terminated (Issues with recruitment.)
First Posted : February 9, 2015
Results First Posted : June 4, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: Modified FOLFOX6 Drug: Docetaxel/Capecitabine Drug: Cisplatin/Irinotecan Drug: Cisplatin/Docetaxel Drug: IRI/EPI Drug: EPI/Docetaxel Drug: Irinotecan/Docetaxel Drug: Docetaxel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma
Actual Study Start Date : February 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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:
  • Oxaliplatin
  • Eloxatin
  • Leucovorin
  • 5-FU
  • 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
  • CPT-11
  • Camptosar

Drug: Cisplatin/Docetaxel
Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1
Other Names:
  • Platinum
  • Taxotere

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
  • CPT-11
  • Epirubicin
  • Camptosar

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:
  • CPT-11
  • Camptosar
  • Taxotere

Drug: Docetaxel
Docetaxel 60-100 mg/m2 IV day 1 every 21 days
Other Name: Taxotere




Primary Outcome Measures :
  1. The Number of Patients With Tumor Size Reduction (Objective Response Rate) [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358863


Locations
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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: John Marshall, MD Georgetown University
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02358863    
Other Study ID Numbers: 2013-0973
First Posted: February 9, 2015    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: September 6, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Leucovorin
Cisplatin
Docetaxel
Capecitabine
Oxaliplatin
Irinotecan
Epirubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors