Clinical Trials /

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

NCT02358863

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
  • Gastric Adenocarcinoma
Recruiting Status:

Terminated

Phase:

N/A

Trial Eligibility

Document

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

Title

  • Brief Title: Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach
  • Official Title: A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma
  • Clinical Trial IDs

    NCT ID: NCT02358863

    ORG ID: 2013-0973

    Trial Conditions

    Esophageal Cancer

    Gastric Cancer

    Trial Interventions

    Drug Synonyms Arms
    Modified FOLFOX6 Oxaliplatin, Eloxatin, Leucovorin, 5-FU, 5-Flourouracil Chemotherapy
    Docetaxel/Capecitabine Taxotere, Xeloda Chemotherapy
    Cisplatin/Irinotecan Platinum, CPT-11, Camptosar Chemotherapy
    Cisplatin/Docetaxel Platinum, Taxotere Chemotherapy
    IRI/EPI Irinotecan, CPT-11, Epirubicin, Camptosar Chemotherapy
    EPI/Docetaxel Taxotere, Epirubicin Chemotherapy
    Irinotecan/Docetaxel CPT-11, Camptosar, Taxotere Chemotherapy
    Docetaxel Taxotere Chemotherapy

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Chemotherapy Experimental 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, Docetaxel/Capecitabine, Cisplatin/Irinotecan, Cisplatin/Docetaxel, IRI/EPI, EPI/Docetaxel, Irinotecan/Docetaxel, Docetaxel

    Eligibility 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 nave

    - 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Objective response rate

    Secondary Outcome Measures

    Trial Keywords