Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer
- Age > 18 years
- Metastatic colorectal carcinoma (stage IV disease).
- Patients must have progressed on one or more prior chemotherapy treatment regimens
including at least one trial of a 5-FU/oxaliplatin based therapy (FOLFOX) in
combination with bevacizumab. Patients must not have had standard chemotherapy within
at least 2 weeks of beginning ascorbic acid treatment provided that they have
recovered from any toxicities that they experienced.
- G6PD status > lower limit of normal
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper
limit (if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine
clearance will be obtained); transaminase (AST/ALT) ≤2.0X upper limit of normal;
bilirubin levels ≥ 2 mg/dL; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥
- Women of childbearing potential will confirm a negative pregnancy test and must
practice effective contraception during the study.
- Willing and able to provide informed consent and participate in the study procedures.
- Patients with evidence of a significant current psychiatric disorder that would
prevent completion of the study as determined by the PI will not be allowed to
- Co-morbid medical condition that would affect survival or tolerance as determined by
the PI. This includes patients who have not fully recovered from toxicities
associated with prior therapy. It also includes subjects who, as determined by the
PI, are at risk of experiencing fluid overload (i.e., congestive heart failure).
- Patients who currently abuse alcohol or drugs.
- Patients with known glomerular filtration rate of <60ml/min or with nephrotic range
- Pregnant or lactating women
- Enrollment in active clinical trial/ experimental therapy or IND study within the
prior 30 days.
- Contraindication for CT or PET/CT as per the PI.
- Patients who are on strong inducers of CYP3A4 which include but are not limited to:
Aminoglutethimide, Bexarotene, Bosentan, Carbamazepine, Dexamethasone, Efavirenz,
Fosphenytoin, Griseofulvin, Modafinil, Nafcillin, Nevirapine, Oxcarbazepine,
Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Rifapentine, St. John's