Niclosamide in Treating Patients with Colon Cancer That Can Be Removed by Surgery

Inclusion Criteria

• Histologically confirmed diagnosis of colon or rectal adenocarcinoma of any clinical stage, previously untreated with chemotherapy or radiotherapy, with a plan to undergo surgical resection no sooner than 7 days from the projected date of study drug initiation
• Karnofsky performance status greater than or equal to 70%
• Absolute neutrophil count (ANC) >= 1500/mL
• Hemoglobin >= 9 g/dL (may transfuse or use erythropoietin to achieve this level)
• Platelets >= 100,000/mL
• International normalized ratio (INR) < 1.5
• Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
• Serum creatinine < 1.5 mg/dL
• Bilirubin < 1.5 mg/dL (except for Gilbert’s syndrome which will allow bilirubin =< 2.0 mg/dL)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN
• Ability to understand and provide signed informed consent that fulfills Institutional Review Board (IRB) guidelines
• Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol

Exclusion Criteria

• Patients with concurrent cytotoxic chemotherapy or radiation therapy
• Known active brain or leptomeningeal metastases (defined as symptomatic metastases) or continued requirement for glucocorticoids for brain or leptomeningeal metastases; treated, asymptomatic metastases are permitted provided the patient has been off steroids for at least 4 weeks prior to day 1 of study drug
• Serious intercurrent chronic or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment
• Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded
• Concurrent (or within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated
• Known active acute or chronic infection including urinary tract infection, human immunodeficiency virus (HIV) or viral hepatitis
• Prior use of niclosamide or allergies to niclosamide
• Concomitant use of strong CYP3A4, CYP1A2, or CYP2C9 substrates
• Pregnant and nursing women are excluded
• Patients with complete bowel obstruction or who are at high risk for gastrointestinal (GI) perforation or severe hemorrhage and patients with inflammatory bowel disease