Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial.

The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.

Key Inclusion Criteria:

• Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach
• Men or women less than 80 years of age
• Performance status 0 or 1
• Life expectancy >12 weeks
• Adequate organ-function
• Written informed consent

Key Exclusion Criteria:

• Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months
• Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach
• Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry
• Prior cumulative dose of >300 mg/m2 of epirubicin
• Grade ≥ 2 side-effects from previous chemotherapy