Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Posit… (NCT01295086) | Clinical Trial Compass
CompletedNot Applicable
Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer
Denmark27 participantsStarted 2011-03
Plain-language 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. Secondary end points are to evaluate progression-free survival and overall survival.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
âś“. Patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease
âś“. HER2-positive tumor tissue (IHC 3 + or FISH positive)
âś“. LVEF \> 50 % (MUGA scan or echocardiography)
✓. Age ≥ 18 years
âś“. No prior chemotherapy
âś“. WHO performance status 0-1
âś“. Life expectancy of at least 3 months
✓. Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
Exclusion criteria
âś•. Patients who cannot complete treatment or evaluation
âś•. 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
âś•. Known hypersensitivity towards any of the study drugs
âś•. Other malignant disease within the last 5 days, except for non-melanoma skin cancer
âś•. Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)
âś•. Pregnant women or nursing women
What they're measuring
1
To determine maximum tolerable dose (MTD) for the combination regime TEX