This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after patients take the drugs capecitabine, oxaliplatin and cetuximab. Capecitabine (also called Xeloda) is a drug that has been approved by the Food and Drug Administration (FDA). Capecitabine has been approved for treatment of cancer of the colon and rectum. Oxaliplatin is another drug approved by the FDA. Oxaliplatin is also approved for treatment of cancer of the colon and rectum. Cetuximab is also a drug approved by the FDA for the treatment of cancer of the colon and rectum, as well as cancer of the head and neck. Capecitabine, oxaliplatin and cetuximab are not approved for gastric or gastroesophageal cancer. They are considered experimental drugs for this study. The purpose of this study is to see how long it takes patients' tumors to progress when they are taking oxaliplatin and capecitabine. Another purpose is to see how many tumors respond to this drug combination. The investigators also want to see how long people live when taking these drugs. The side effects of this drug combination will also be evaluated. This study will also measure the levels of certain genes (the cell's blueprint) in tumors. These genes affect how peoples' bodies react to the cancer drugs. Genes will also be measured in the blood. The investigators want to see how these genes can predict response to these study drugs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, United States
Rate of Progression-Free Survival (PFS) at Month 4
Progression-free survival will be measured from the start of treatment until the time the patient is first recorded as having disease progression, or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last visit for tumor measurement.
Time frame: every 2 cycles (6 weeks), up to 4 months.
Time to Progression
The overall time to progression in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin. This differs from 4 months PFS rate outcome data, which assesses the progression-free survival at 4 months.
Time frame: every 2 cycles (6 weeks), through study completion up to 2 years, 7 months
Number of Participants Who Experienced Toxicities During the Study Drug Regimen
Time frame: About 2 years, 7 months
Overall Response Rate
To determine overall response rate in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin
Time frame: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 months
Overall Survival
To determine overall survival in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin
Time frame: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 months
Progression-free Survival (PFS)
Progression-free survival (PFS), Median (95%CI), months
Time frame: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 months
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