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Trial record 1 of 1 for:    NCT01295086
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Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01295086
Recruitment Status : Unknown
Verified January 2015 by Per Pfeiffer, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : February 14, 2011
Last Update Posted : January 21, 2015
Aalborg University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Drug: Docetaxel Drug: Oxaliplatin Drug: Capecitabine Drug: Trastuzumab Not Applicable

Detailed Description:

Primary aim:

To define the maximum tolerated dose of the combination 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 aims:

Estimating response-rate, progression free survival and overall survival


This dose-finding study is planned to include 15 patients with HER2 positive gastro-esophageal cancer, adenocarcinoma. Patients will be included in cohorts of three at progressively higher dose levels.

Chemotherapy will be repeated day 1 every third week to a maximum of eight cycles. Treatment with trastuzumab will continue until disease progression. Dose-limiting toxicity (DLT) will be evaluated after the first cycle. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continued if 0/3 or 1/6 patients experience DLT.

Patients will be evaluated with a ct- scan at baseline and after every three cycles to exclude progression and evaluate response. Response is assessed by investigators according to RECIST version 1.1.

Blood counts regarding tumour biology will be collected at baseline before 2nd, 4th and 7th cycle and 4 weeks after ended treatment. After completion of treatment patients will be followed every third month until progression or death.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Determination of Taxotere®, Eloxatin® and Xeloda® (TEX)in Combination With Herceptin® as First-line Treatment for Patients With HER2 Positive Non-resectable Oesophagus, Cardia or Gastric Cancer (ECV)
Study Start Date : March 2011
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Her-TEX Drug: Docetaxel
42, 51 or 60 mg/m² day 1 every 3. week
Other Name: Taxotere

Drug: Oxaliplatin
100 mg/m² day 1 every 3. week
Other Name: Eloxatin

Drug: Capecitabine
1250 mg/² continuously
Other Name: Xeloda

Drug: Trastuzumab
Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week
Other Name: Herceptin

Primary Outcome Measures :
  1. To determine maximum tolerable dose (MTD) for the combination regime TEX [ Time Frame: 2 years ]
    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.

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 years ]
    Time from inclusion to disease progression or death of any cause.

  2. Survival [ Time Frame: 4 years ]
    Time from inclusion to death of any cause.

  3. Response rate [ Time Frame: 3 years ]
    According to RECIST version 1.1.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease
  2. HER2-positive tumor tissue (IHC 3 + or FISH positive)
  3. LVEF > 50 % (MUGA scan or echocardiography)
  4. Age ≥ 18 years
  5. No prior chemotherapy
  6. WHO performance status 0-1
  7. Life expectancy of at least 3 months
  8. Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
  9. 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
  10. Creatinine clearance ≥ 50 ml/min. Calculated with the Cockroft-Gault formula
  11. No neuropathy
  12. Planned treatment start within 8 days after inclusion

Exclusion Criteria:

  1. Patients who cannot complete treatment or evaluation
  2. 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
  3. Known hypersensitivity towards any of the study drugs
  4. Other malignant disease within the last 5 days, except for non-melanoma skin cancer
  5. Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)
  6. Pregnant women or nursing women
  7. Physical or mental conditions which may prevent absorption of oral treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01295086

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Contact: Per Pfeiffer, Professor +45 6541 2921
Contact: Katrine Rahbek Schønnemann, MD +45 6541 2921

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Aalborg University Hospital Recruiting
Aalborg, Denmark, 9100
Contact: Mette Yilmaz, MD    +45 9932 1111      
Principal Investigator: Mette Yilmaz, MD         
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Morten Ladekarl, MD    +45 8949 4444      
Principal Investigator: Morten Ladekarl, MD         
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Lene Bæksgaard, MD    +45 3545 3545      
Principal Investigator: Lene Bæksgaard, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Katrine Rahbek Schoennemann, MD    +45 6541 2921   
Principal Investigator: Katrine Rahbek Schoennemann, MD         
Sponsors and Collaborators
Odense University Hospital
Aalborg University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
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Study Chair: Per Pfeiffer, Professor Odense University Hospital

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Responsible Party: Per Pfeiffer, Professor, Odense University Hospital Identifier: NCT01295086     History of Changes
Other Study ID Numbers: Her-TEX
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Per Pfeiffer, Odense University Hospital:
Adenocarcinoma of the gastro-esophageal
Dose finding
Taxotere (Docetaxel)
Eloxatin (Oxaliplatin)
Xeloda (Capecitabine)
Herceptin (Trastuzumab)

Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents, Immunological