Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT01928290
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Neoplasms
  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
  • Trastuzumab — DRUG
  • Oxaliplatin — DRUG
  • Leucovorin — DRUG
  • Fluorouracil — DRUG

Study Details

This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Key Dates

Start date
Nov 8, 2013
Status verified
Aug 2020
Primary completion
Dec 3, 2018
Completion
Oct 28, 2019

Study Design

Enrollment
67 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: FOLFIRINOX (HER2-negative)
    Irinotecan 180 mg/m2 IV on Days 1 \& 15. Oxaliplatin 85 mg/m2 IV on Days 1 \& 15. Leucovorin 400 mg/m2 IV on Days 1 \& 15. Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15.
  • Experimental: Arm B: FOLFIRINOX & Trastuzumab (HER2-positive)
    Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles. Irinotecan 180 mg/m2 IV on Days 1 \& 15. Oxaliplatin 85 mg/m2 IV on Days 1 \& 15. Leucovorin 400 mg/m2 IV on Days 1 \& 15. Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15.

Primary Outcome Measure

Number of Participants With an Objective Response [ Time Frame: Through completion of treatment (estimated to be 4 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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