Cedars-Sinai Medical Center
This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.
Inclusion Criteria: * Stage IV patients with resectable liver predominant metastatic colorectal cancer (new diagnosis or recurrent) referred to Cedars Sinai Medical Center for oxaliplatin based systemic therapy. * Age ≥ 18 years. * Patients who are planning to undergo liver resection following oxaliplatin based chemotherapy treatment. * ECOG Performance Status 0-2 or Karnofsky Performance Status (KPS) ≥ 60%. * Demonstrate adequate organ and marrow function (within 28 days of study treatment initiation) * Female subjects of childbearing potential should have a negative urine or serum pregnancy…
mFOLFOX6 or CAPOX
(400 mg tablet): 2 tablets taken orally AM and 1 tablet PM daily (total 1,200 mg daily) prior to surgical resection
At 1-Month
Arctuva estimate
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