AdenocarcinomaNCT01295086
Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer
A study testing Docetaxel, Oxaliplatin and Capecitabine in people with Adenocarcinoma, run by Odense University Hospital at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Docetaxel, Oxaliplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesDenmark
- Study dates
- Mar 2011to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
- Planned treatment start within 8 days after inclusion
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, 9100
Aarhus University Hospital
Aarhus, 8000
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
About this study
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)
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.
Read the 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.
- Conditions
- Adenocarcinoma
- Being tested
- Docetaxel, Oxaliplatin, Capecitabine, Trastuzumab
- Keywords
- Adenocarcinoma of the gastro-esophageal, Her2, Dose finding, Taxotere (Docetaxel), Eloxatin (Oxaliplatin), Xeloda (Capecitabine), Herceptin (Trastuzumab)
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
42, 51 or 60 mg/m² day 1 every 3. week
OxaliplatinDrug
Also called Eloxatin
100 mg/m² day 1 every 3. week
CapecitabineDrug
Also called Xeloda
1250 mg/² continuously
TrastuzumabDrug
Also called Herceptin
Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week
| Study group | Role | What they receive |
|---|---|---|
| Her-TEX | Experimental | Not described Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Progression free survival
Time from inclusion to disease progression or death of any cause.
Measured: 3 years
Survival
Time from inclusion to death of any cause.
Measured: 4 years
Response rate
According to RECIST version 1.1.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2014
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Per Pfeiffer, Odense University Hospital
- Investigators
- Per Pfeiffer, Professor, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295086
- Sponsor's protocol ID
- Her-TEX
- Status last verified
- Oct 2020
- First submitted
- 11 Feb 2011
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01295086
- Acronym / sponsor ID
- Her-TEX
- Conditions
- Adenocarcinoma
- Keywords
- Adenocarcinoma of the gastro-esophageal, Her2, Dose finding, Taxotere (Docetaxel), Eloxatin (Oxaliplatin), Xeloda (Capecitabine), Herceptin (Trastuzumab)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Mar 2011 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Her-TEX | Experimental | Drug: Docetaxel, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Trastuzumab |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere42, 51 or 60 mg/m² day 1 every 3. week | Drug | Her-TEX |
| OxaliplatinAlso: Eloxatin100 mg/m² day 1 every 3. week | Drug | Her-TEX |
| CapecitabineAlso: Xeloda1250 mg/² continuously | Drug | Her-TEX |
| TrastuzumabAlso: HerceptinTrastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week | Drug | Her-TEX |
Primary outcome
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.
3 secondary outcomes
Progression free survival
Time frame: 3 years
Survival
Time frame: 4 years
Response rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
Related trials for Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Pfeiffer, Professor study chair
Odense University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel, Oxaliplatin and Capecitabine in people with Adenocarcinoma, run by Odense University Hospital at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine maximum tolerable dose (MTD) for the combination regime TEX (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.