Last updated on June 2010

Epirubicin Oxaliplatin and Capecitabine or Docetaxel and Oxaliplatin in Treating Patients With Advanced Esophageal Cancer Gastroesophageal Junction Cancer or Stomach Cancer


Brief description of study

RATIONALE: Drugs used in chemotherapy, such as epirubicin, oxaliplatin, capecitabine, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating esophageal cancer, gastroesophageal junction cancer, or stomach cancer. PURPOSE: This randomized phase II trial is studying how well giving epirubicin together with oxaliplatin and capecitabine works compared with giving docetaxel together with oxaliplatin in treating patients with advanced esophageal cancer, gastroesophageal junction cancer, or stomach cancer.

Detailed Study Description

OBJECTIVES: Primary - Compare the response rate in patients with advanced esophageal, gastroesophageal junction, or gastric cancer treated with epirubicin hydrochloride, oxaliplatin, and capecitabine vs docetaxel and oxaliplatin. Secondary - Compare the time to progression, survival, and quality of life of patients treated with these regimens. - Compare the toxicities associated with these regimens in these patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive epirubicin hydrochloride IV over 10-15 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-21. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients complete quality-of-life questionnaires periodically. After completion of study treatment, patients are followed periodically.

Clinical Study Identifier: NCT00806949

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