GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

Exclusion Criteria

• •Has central nervous system metastasis
• •Has bony metastasis as the sole metastasis
• •Has other concomitant or previous malignancy in the past 3 years, except:
• •* adequately treated in situ carcinoma of the uterine cervix;
• •* basal or squamous cell carcinoma of the skin; and/or
• •* melanoma in situ.
• •Is receiving concomitant anti-neoplastic treatment; has received radiation therapy in the past 3 weeks; has been treated with anti-angiogenesis agents, including bevacizumab, in the past 4 weeks; or has been treated with any other chemotherapeutic agents in the past 4 weeks (6 weeks for mitomycin C and nitrosoureas).
• •Has an active infection
• •Has congestive heart failure (Class III or IV in the New York Heart Association functional classification system)
• •Has a hemoglobin level of \< 8.5 gm/dL
• •Has a platelet count of \< 100,000/mm3
• •Has a neutrophil count of \< 1,500/mm3
• •Has a serum creatinine level of \> 2.0 mg/dL
• •Has liver aminotransferase and alkaline phosphatase levels that are \> 2.5 times the laboratory's upper limit of normal (ULN) in a subject with no liver metastases, and levels that are \> 5 times the laboratory's ULN in a subject with liver metastases
• •Has a total bilirubin level that is \> 2 times the laboratory's ULN
• •Has pulmonary DLCO \< 60% of predicted
• •Has known or clinically suspected infection with human immunodeficiency virus (HIV)
• •Has participated within 30 days, or will participate concurrently, in another investigational drug or vaccine study
• •Has a history of drug or alcohol dependence in the past 3 years
• •Has other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
• •Has known intolerance to 5- FU
• •Has previously participated in a GM-CT-01 clinical trial
• •Has known hypersensitivity to GM-CT-01 or any of its components