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.
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%.
Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
No other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) or investigational agent may be used from 28 days prior to registration and until the end-of-study visit.
Has previously received chemotherapy for metastatic disease (neoadjuvant or adjuvant therapy is allowed as long as treatment was completed ≥6 months prior to recurrence).
Has pre-existing grade ≥ 3 neuropathy precluding use of oxaliplatin.
Single group
Standard of care oxaliplatin-based chemotherapy
RadiationmFOLFOX6 or CAPOX
S-adenosylmethionine (SAMe) supplement
Dietary supplement(400 mg tablet): 2 tablets taken orally AM and 1 tablet PM daily (total 1,200 mg daily) prior to surgical resection
Surgery
Procedure/SurgeryAt 1-Month
To evaluate the efficacy of SAMe in preventing oxaliplatin associated liver injury as determined by lack of injury on histopathologic analysis in patients with liver only stage IV colorectal cancer.
To identify the effect of SAMe in preventing oxaliplatin associated liver injury as determined by lack of injury on histopathologic analysis in patients with liver only stage IV colorectal cancer. Improvement in liver injury will be measured by the degree/histopathologic grade of liver injury utilizing the Combined Vascular Injury (CVI) Score in non-cancerous liver tissue post therapy compared to historical controls. CVI score will evaluate and grade sinusoidal dilation, small vessel loss/obliteration, focal hepatocyte plate disruption, parenchymal extinction lesions, nodular regenerative hyperplasia, peliosis, and veno-occlusive like changes. Rate of sinusoidal obstruction syndrome (SOS), as measured by CVI Score, ranging from 0-13. A CVI score of 3 or more indicates SOS. Compared to historical controls.
To Estimate the Objective Response Rate (ORR) of SAMe when taken with oxaliplatin based chemotherapy.
To evaluate the efficacy of SAMe during oxaliplatin based therapy in stage IV liver-only colorectal cancer, Objective Response Rate (ORR) will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) per RECIST 1.1. ORR will be assessed from screening until EOT.
To evaluate changes in average estimated blood loss (EBL) in patients undergoing liver resection as compared to historical controls.
Calculate surgical EBL in all patients undergoing resection
To evaluate length of hospital stay (LOS) in patients undergoing liver resection as compared to historical controls.
Length of hospital stay (LOS) to historical controls, the following will be conducted: ii. Calculate hospital LOS in all patients undergoing resection iii. Account for 30-day readmission
To examine if SAMe can decrease treatment-delays in oxaliplatin-based chemotherapy.
Incidence of oxaliplatin treatment delays will be evaluated by recording the following: If treatment delay occurred and time point/duration of treatment delay
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Cedars-Sinai Medical Center
Lead sponsor
Jarrow Formulas Inc
Collaborator
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