This study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a leukemia called CML (increase of white blood cells) after failure of standard therapy. It is also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in the digestive tract). This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Capecitabine and imatinib mesylate will both be taken by mouth twice a day
USC/Norris Cancer Center
Los Angeles, California, United States
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Gleevec in combination with a fixed dose of Xeloda po bid daily in patients with colon cancer.
Time frame: 4 weeks
To determine the time to progression, survival and response rate.
Time frame: Until Patient goes off study
To obtain preliminary data on molecular correlates to determine clinical efficacy
Time frame: Until Patient Goes off study
Toxicity.
Time frame: 30 days after patient receives last drug dose
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