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)
18 Years
85 Years
Both
Adenocarcinoma
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine maximum tolerable dose (MTD) for the combination regime TEX
Outcome Description:
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.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Per Pfeiffer, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Odense University Hospital
Authority:
Denmark: Danish Dataprotection Agency
Study ID:
Her-TEX
NCT ID:
NCT01295086
Start Date:
March 2011
Completion Date:
January 2015
Related Keywords:
- Adenocarcinoma
- Adenocarcinoma of the gastro-esophageal
- Her2
- Dose finding
- Taxotere (Docetaxel)
- Eloxatin (Oxaliplatin)
- Xeloda (Capecitabine)
- Herceptin (Trastuzumab)
- Adenocarcinoma
- Adenocarcinoma, Mucinous
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