Full TitlePhase 1-2 Study of ADI-PEG 20 plus FOLFOX in Subjects with Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma
FOLFOX is a combination of anticancer drugs (folinic acid, fluorouracil, and oxaliplatin) used in the standard treatment of some digestive cancers. ADI-PEG 20 is an investigational drug that starves cancer cells of a nutrient called arginine, which some digestive cancers need to survive. Normal cells do not need arginine.
The purpose of this study is to determine the highest dose of ADI-PEG 20 that can be given safely with FOLFOX in patients with advanced digestive cancers that persist despite therapy. ADI-PEG 20 is given as an injection, while FOLFOX is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an advanced digestive cancer that has come back or spread after therapy or has stopped responding to standard therapy.
- At least 4 weeks must pass between completion of prior treatment and entry into the study (though radiation therapy is permitted within 2 weeks of entry if it was given to relieve symptoms).
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.