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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT02358863
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified FOLFOX6 — DRUG
    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 — DRUG
    Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14
  • Cisplatin/Irinotecan — DRUG
    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 — DRUG
    Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1
  • IRI/EPI — DRUG
    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 — DRUG
    Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2
  • Irinotecan/Docetaxel — DRUG
    Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1
  • Docetaxel — DRUG
    Docetaxel 60-100 mg/m2 IV day 1 every 21 days

Study Details

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.

Key Dates

Start date
Feb 28, 2015
Status verified
Aug 2017
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20057-

Find similar trials in Washington D.C., DC

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Georgetown University· Washington D.C., DC

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