Adequate hepatic parameters (bilirubin \< 2.0, Alk. Phos \< 5 times normal, ALT \< 5 times normal)
Adequate renal function (creatinine \< 2.0)
Performance status ECOG 0-2
0-2 prior lines of chemotherapy for metastatic colorectal cancer are allowed. Prior 5-FU/LV or capecitabine allowed either in the adjuvant setting, or in the metastatic setting or both.
Absence of other serious concurrent medical illnesses
Evaluable or measurable disease for phase I; measurable disease only for phase II
You may not be if
Histologies other than adenocarcinoma
Previous grade 4 toxicity to 5-FU +/- LV or capecitabine
Uncontrolled brain metastases
Chronic diarrhea (greater than five bowel movements per day)
Previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with Mitomycin or nitrosoureas)
Major surgery within 2 weeks before study entry
Known allergic sensitivity to leucovorin
Prior exposure to IFN-γ
Previous hematopoietic growth factor (e.g. epoetin alfa or darbepoietin less than 2 weeks prior to study day 1)
Pregnancy or breast feeding. Women of child-bearing potential must have a negative pregnancy test before the first dose.
Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
