Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment

Exclusion Criteria

• •Evidence of recurrence of rectal cancer prior to the start of study treatment
• •Any previously untreated or concurrent cancer that is distinct in primary site or histology from rectal cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before starting study drug are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form)
• •Anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 4 weeks prior to entering the study (signing of consent form) or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients on hormonal or bisphosphonate treatment for non-cancer related conditions are eligible
• •Inability to start study treatment within 12 weeks following the completion of curative intent therapy for rectal adenocarcinoma
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication; minor procedures such as diagnostic laparoscopy, percutaneous biopsy and paracentesis within 14 days before start of study medication
• •Patients who have not recovered from the surgical resection of rectal cancer such as wound dehiscence, non-healing wound, wound infection and fistula
• •Prior use of regorafenib
• •Gastrointestinal conditions that may significantly affect the absorption of regorafenib
• •Uncontrolled hypertension (systolic pressure \> 140 mmHg or diastolic pressure \> 90 mmHg on repeated measurement) despite optimal medical management
• •Evidence or history of bleeding diathesis or coagulopathy
• •Any hemorrhage or bleeding event \>= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 within 4 weeks prior to start of study medication
• •Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 3 months prior to the initiation of study treatment
• •Patients with phaeochromocytoma
• •Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
• •Ongoing infection \> CTCAE grade 2
• •Patients with seizure disorder requiring medication
• •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
• •Pleural effusion or ascites that causes respiratory compromise (\>= grade 2 dyspnea CTCAE)
• •History of organ allograft (including corneal transplant)
• •Pregnant or nursing female patients
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina pectoris (defined as anginal symptoms at rest, new-onset angina within 3 months before study treatment initiation, or myocardial infarction within 6 months before study treatment initiation), cardiac arrhythmia (which require anti-arrhythmic therapy other than beta blockers or digoxin), active coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements
• •Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
• •Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids; however, prophylactic anticoagulation as described below is allowed:
• •* Low dose warfarin (1 mg orally, once daily) with PT-INR =\< 1.5 is permitted; infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on regorafenib therapy; therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes
• •* Low dose aspirin (=\< 100 mg daily)
• •* Prophylactic doses of heparin
• •Are taking strong cytochrome P (cytochrome P450, family 3, subfamily A, polypeptide 4 \[CYP3A4\]) inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort/Hypericum perforatum)
• •Unwilling or unable to follow protocol requirements
• •Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
• •Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results