MedTrace Logo

Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients

NCT00526110 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2016-10-31

Study results available
· View outcomes & findings →

Summary

Phase I Objectives

Primary:

1\. The primary objective of this study is to determine the maximum tolerated dose (MTD) of Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated, locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).

Secondary:

1\. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination.

Phase II Objectives

Primary:

1\. To assess time to cancer progression to D-FOX treatment regimen.

Secondary:

1. To assess response rate to D-FOX treatment regimen.
2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination treatment regimen.
3. Determine overall survival.
4. Perform an exploratory investigation into the effect of D-FOX on phenotypic abnormalities in blood.

Conditions

  • Gastrointestinal Diseases

Interventions

DRUG

5-Fluorouracil

2.2 Gm/m\^2 IV over 48 hours on Day 1.

DRUG

Docetaxel

20 mg/m\^2 IV over 60 minutes

DRUG

Oxaliplatin

85 mg/m\^2 IV over 120 minutes on Day 1.

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jaffer Ajani, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00526110 on ClinicalTrials.gov