Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer
NCT ID: NCT01295086
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2011-03-31
2018-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Her-TEX
Docetaxel
42, 51 or 60 mg/m² day 1 every 3. week
Oxaliplatin
100 mg/m² day 1 every 3. week
Capecitabine
1250 mg/² continuously
Trastuzumab
Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week
Interventions
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Docetaxel
42, 51 or 60 mg/m² day 1 every 3. week
Oxaliplatin
100 mg/m² day 1 every 3. week
Capecitabine
1250 mg/² continuously
Trastuzumab
Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Aarhus University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Per Pfeiffer
Professor
Principal Investigators
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Per Pfeiffer, Professor
Role: STUDY_CHAIR
Odense University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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Her-TEX
Identifier Type: -
Identifier Source: org_study_id