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)
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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Per Pfeiffer, Professor
Odense University Hospital
Denmark: Danish Dataprotection Agency