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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Odense University Hospital
Sponsor:
Collaborators:
Aalborg Universityhospital
Aarhus University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01295086
First received: February 11, 2011
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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 Intervention
Adenocarcinoma
Drug: Docetaxel
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Trastuzumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • To determine maximum tolerable dose (MTD) for the combination regime TEX [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Time from inclusion to disease progression or death of any cause.

  • Survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Time from inclusion to death of any cause.

  • Response rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    According to RECIST version 1.1.


Estimated Enrollment: 15
Study Start Date: March 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Methods:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295086

Contacts
Contact: Per Pfeiffer, Professor +45 6541 2921 per.pfeiffer@ouh.regionsyddanmark.dk
Contact: Katrine Rahbek Schønnemann, MD +45 6541 2921 k.shoennemann@ouh.regionsyddanmark.dk

Locations
Denmark
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    k.schoennemann@ouh.regionsyddanmark.dk   
Principal Investigator: Katrine Rahbek Schoennemann, MD         
Sponsors and Collaborators
Odense University Hospital
Aalborg Universityhospital
Aarhus University Hospital
Rigshospitalet, Denmark
Investigators
Study Chair: Per Pfeiffer, Professor Odense University Hospital
  More Information

No publications provided

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01295086     History of Changes
Other Study ID Numbers: Her-TEX
Study First Received: February 11, 2011
Last Updated: October 11, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
Adenocarcinoma of the gastro-esophageal
Her2
Dose finding
Taxotere (Docetaxel)
Eloxatin (Oxaliplatin)
Xeloda (Capecitabine)
Herceptin (Trastuzumab)

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Docetaxel
Trastuzumab
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 30, 2014