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S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

NCT01498289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2019-11-07

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells.

PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.

Conditions

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • Gastric Cancer

Interventions

DRUG

FOLFOX regimen

Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium.

DRUG

docetaxel

30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

DRUG

fluorouracil

400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

DRUG

irinotecan hydrochloride

65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.

DRUG

leucovorin calcium

400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.

DRUG

oxaliplatin

85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Syma Iqbal, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2018-03-31
Completion
2019-09-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01498289 on ClinicalTrials.gov