Gastric Cancer Clinical Trial
Official title:
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with
capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
OBJECTIVES:
Primary
- Determine the objective tumor response rate of patients with advanced adenocarcinoma of
the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin
and capecitabine.
Secondary
- Determine the time to progression and overall survival of patients treated with this
regimen.
- Determine the toxic effects of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice
daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of
disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2
additional courses after CR.
Quality of life is assessed at baseline and then every 3 weeks (prior to each course of
chemotherapy).
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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