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
Inability to provide written and informed consent
Uncontrolled hypertension
History of deep venous thrombosis or CVA
Prior exposure to bevacizumab
Proteinuria \> 500 mg/24 hr
Clareo Health | Study of Gamma Interfereon in Metastatic Colorectal Carcinoma
