This study is for patients with cancer of the esophagus. This study uses the drugs irinotecan, cisplatin and celecoxib. Irinotecan (also known as CPT-11) was recently approved by the U.S. Food and Drug Administration (FDA) for use in colon cancer, but has not been approved by the FDA for use in the treatment of cancers of the esophagus. Cisplatin is a drug that is commonly used to treat patients with cancer of the esophagus. We are combining these two chemotherapy drugs with a drug called Celebrex. Celebrex (also called Celecoxib) is an oral medication that is approved by the FDA for pain in the treatment of arthritis. There is some information to suggest that this drug may have anti-cancer activity. In prior studies combining irinotecan and cisplatin, tumors of the esophagus have been shown to shrink. We are adding Celebrex to these drugs to see if it makes the drugs work better to shrink cancer or cause fewer side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
U.S.C. / Norris Comprehensive Cancer Center
Los Angeles, California, United States
To assess the time to progression of CPT-11 and cisplatin in combination with celebrex in patients with metastatic or unresectable carcinoma of the esophagus
To assess response rate and overall survival in these patients.
To assess the toxicity of this regimen.
To identify molecular correlates of response and survival (gene expression and genomic polymorphism of enzymes involved in drug metabolism, DNA repair, apoptosis)
To evaluate the effects of celebrex on a variety of histological and molecular biomarkers of angiogenesis, including in vitro activity assays on endothelial cell proliferation, migration and invasion.
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