Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

Inclusion Criteria:

• Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease
• Measurable tumor
• Serum creatinine < 1.5 mg/dl
• Total bilirubin < 2.0 mg/dl
• AST < 5 x ULN
• ANC > 1,500/mm3
• Platelets > 100,000/mm3
• Hemoglobin > 9.0 gm/dl
• Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment
• 18 years of age or older
• ECOG performance status of less than or equal to 2
• Life expectancy of greater than 12 weeks

Exclusion Criteria:

• Prior treatment with mitomycin C or nitrosourea compounds
• Prior treatment with capecitabine or thalidomide
• Clinically apparent central nervous system metastases or carcinomatous meningitis
• Peripheral neuropathy of grade 2 or greater severity
• Myocardial infarction in the past 6 months
• Major surgery in the past 2 weeks
• Uncontrolled serious medical or psychiatric illness
• Pregnant or lactating women
• Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Known allergy to 5-FU