NCT01295086

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

3.7 years

First QC Date

February 11, 2011

Last Update Submit

October 29, 2020

Conditions

Adenocarcinoma

Keywords

Adenocarcinoma of the gastro-esophagealHer2Dose findingTaxotere (Docetaxel)Eloxatin (Oxaliplatin)Xeloda (Capecitabine)Herceptin (Trastuzumab)

Outcome Measures

Primary Outcomes (1)

  • To determine maximum tolerable dose (MTD) for the combination regime TEX

    The investigators have planned to examine 3 dose levels including 3 patients at each level with escalating doses of docetaxel from 42 mg/m² to 60 mg/m² and fixed doses of oxaliplatin (100 mg/m²), capecitabine 625 mg/m² x 2 and trastuzumab 6 mg/kg.

    2 years

Secondary Outcomes (3)

  • Progression free survival

    3 years

  • Survival

    4 years

  • Response rate

    3 years

Study Arms (1)

Her-TEX

EXPERIMENTAL
Drug: DocetaxelDrug: OxaliplatinDrug: CapecitabineDrug: Trastuzumab

Interventions

DocetaxelDRUG

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

Also known as: Taxotere
Her-TEX
OxaliplatinDRUG

100 mg/m² day 1 every 3. week

Also known as: Eloxatin
Her-TEX
CapecitabineDRUG

1250 mg/² continuously

Also known as: Xeloda
Her-TEX
TrastuzumabDRUG

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

Also known as: Herceptin
Her-TEX

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease
  • HER2-positive tumor tissue (IHC 3 + or FISH positive)
  • LVEF \> 50 % (MUGA scan or echocardiography)
  • Age ≥ 18 years
  • No prior chemotherapy
  • WHO performance status 0-1
  • Life expectancy of at least 3 months
  • Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
  • Bilirubin ≤ 1.5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL. In case of liver metastases no UNL for ASAT and ALAT
  • Creatinine clearance ≥ 50 ml/min. Calculated with the Cockroft-Gault formula
  • No neuropathy

You may not qualify if:

  • Patients who cannot complete treatment or evaluation
  • Any condition or treatment which after the opinion of the investigator may expose the patients to a risc or influence the purpose of the study
  • Known hypersensitivity towards any of the study drugs
  • Other malignant disease within the last 5 days, except for non-melanoma skin cancer
  • Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)
  • Pregnant women or nursing women
  • Physical or mental conditions which may prevent absorption of oral treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Adenocarcinoma

Interventions

DocetaxelOxaliplatinCapecitabineTrastuzumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Per Pfeiffer, Professor

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2014

Study Completion

January 1, 2018

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

DK(4)