Marine Omega 3 Fatty Acid in Treating Patients with Stage I-III Colorectal Cancer or Colorectal Mass or Polyp Undergoing Surgery
This phase II trial studies how well a marine omega 3 fatty acid (AMR101) works in treating patients with stage I-III colorectal cancer or colorectal mass or polyp undergoing surgery. Marine omega 3 fatty acid reduces inflammation in the human body which may influence the immune system and improve the outcome of colon cancer patients treated with immunotherapy.
Inclusion Criteria
- Participants have histologically confirmed adenocarcinoma of the colorectum that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%).
- Patients must be sufficiently healthy to undergo surgery.
- The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Subjects must be able and willing to follow study procedures and instructions.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Participants who are planning to receive post-operative chemotherapy. NOTE: In the event that a patient plans to receive post-operative chemotherapy after meeting with a medical oncologist at a later time, the patient will not be considered ineligible and collected research samples will still be utilized.
- Participants who are receiving any other investigational agents.
- Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
- Inability or unwillingness to swallow pills.
- History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications.
- History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to MO3PUFA.
- Currently using or have used any fish oil supplement at any dose more than once per week within the last month.
- Regularly consuming more than three servings of fish per week.
- Known bleeding tendency/condition (e.g. von Willebrand disease).
- Current use of anticoagulants including heparin, warfarin, dalteparin sodium, bivalirudin, argatroban, lepirudin, heparin sodium, heparin/dextrose, and an unwillingness or inability to discontinue anticoagulants.
- Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.
- The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with AMR101. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.
- Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection. Participants with these infections are ineligible because they are at increased risk of significant complications in the perioperative period, and because fresh tissue from patients with these infections cannot be harvested for research purposes, per institutional policy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03661047.
PRIMARY OBJECTIVE:
I. To measure the effect of daily 4-gram icosapent ethyl (AMR101) treatment on marine omega-3 polyunsaturated fatty acid (MO3PUFA) composition in colonic mucosa tissue.
SECONDARY OBJECTIVES:
I. To measure the effect of MO3PUFA treatment on the following immune markers:
Ia. CD8+ T cell: regulatory T (Treg) cell ratios.
Ib. Gene expression profile of tissue.
Ic. Protein levels in the tissue of T cell inhibitory markers, including FOXP3, IL10, LAG-3 and CD49b, and immune checkpoints, including CTLA-4, TIGIT, TIM-3, PD-1 and PD-L1.
II. To measure the effect of MO3PUFA treatment on the gut microbiome.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive icosapent ethyl orally (PO) twice daily (BID) for up to 30 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive placebo PO BID for up to 30 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants will be followed up annually.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAndrew T Chan
- Primary ID18-097
- Secondary IDsNCI-2018-02367
- ClinicalTrials.gov IDNCT03661047