Adenocarcinoma of the Gastroesophageal Junction Clinical Trial
Official title:
Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma
Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).
PRIMARY OBJECTIVES:
I. To assess the total response rate of the oxaliplatin, irinotecan and capecitabine drug
combination in advanced gastric/esophageal junction carcinoma.
II. To assess the duration of total responses of the oxaliplatin, irinotecan and
capecitabine drug combination in advanced gastric/esophageal junction carcinoma.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8,
15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses
repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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