Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Capecitabine; Carboplatin; Docetaxel; Epirubicin; Oxaliplatin

Criteria

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