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Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

NCT01295086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-11-02

No results posted yet for this study

Summary

The primary aim of this dose-finding study is to determine the maximum tolerated dose of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first-line treatment in patients with HER2-positive advanced gastro-esophageal cancer. Secondary end points are to evaluate progression-free survival and overall survival.

Conditions

  • Adenocarcinoma

Interventions

DRUG

Docetaxel

42, 51 or 60 mg/m² day 1 every 3. week

DRUG

Oxaliplatin

100 mg/m² day 1 every 3. week

DRUG

Capecitabine

1250 mg/² continuously

DRUG

Trastuzumab

Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Per Pfeiffer, Professor · Odense University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-11-30
Completion
2018-01-31

Countries

  • Denmark

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 NCT01295086 on ClinicalTrials.gov