RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.
OBJECTIVES: Primary * Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin. Secondary * Determine the tolerability and toxicity of this regimen in these patients. * Determine the median and progression-free survival of patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Response Rate as Determined by RECIST.
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Every 6 weeks through study completion for up to about 18 weeks
Number of Adverse Events
Time frame: From the start of study treatment through study completion for up to about 18 weeks
Progression-free Survival
Time frame: Every 6 weeks through study completion for up to about 18 weeks
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