Patients
pleural effusion, ascites, leptomeningeal disease, adenocarcinoma of the colon, cirrhosis, pulmonary dysfunction, hypercalcemia, pericardial effusion, infection, alcohol abuse, metabolic dysfunction, hepatitis
CARCINOMATOUS MENINGITIS, ASCITES, TREATMENT COMPLICATIONS, ADENOCARCINOMA OF THE COLON, HIV INFECTION, DISEASE, MALABSORPTION SYNDROME, CIRRHOSIS, DISEASES, LIVER DISEASE, HYPERCALCEMIA, INFECTION, SPINAL CORD HEMORRHAGE, CNS METASTASES, ONCOLOGY, HEPATITIS
Patients 18 years or older with locally advanced, recurrent or metastatic incurable adenocarcinoma of the colon or rectum harboring a Patients were included based on the following inclusion criteria: disease that had progressed after at least one available standard therapy, or for which standard therapy has shown to be ineffective or intolerable, or for which a clinical trial of an investigational agent is a recognized standard of care; evaluable or measurable disease per RECIST v1.1; Eastern Cooperative Oncology Group performance status of 1 or lower (a five-point scale where higher numbers reflect greater disability); life expectancy ≥12 weeks; adequate hematologic and organ function within 14 d before initiation of study treatment defined as absolute neutrophil count ≥1,200/µl, hemoglobin ≥9 g dlPatients were excluded based on the following criteria: inability/unwillingness to swallow pills; inability/unwillingness to comply with study or follow-up procedures; malabsorption syndrome or other condition that would interfere with enteral absorption; active, untreated CNS metastases (previously treated CNS metastases were allowed if they had measurable or evaluable disease outside the CNS, no history of intracranial or spinal cord hemorrhage, no ongoing requirement for corticosteroids for CNS metastases (with corticosteroids discontinued for ≥2 weeks before enrollment and no ongoing symptoms attributed to CNS metastases), no stereotactic radiation within 7 d or whole-brain radiation within 14 d before C1D1, and no evidence of interim progression between completion of CNS-directed therapy and screening radiographic study); leptomeningeal disease or carcinomatous meningitis; uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures biweekly or more frequently; any active infection that could impact patient safety or serious infection requiring intravenous antibiotics within 7 d before C1D1; clinical history of liver disease, including viral or other hepatitis, current alcohol abuse or cirrhosis; known HIV infection; any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications; uncontrolled hypercalcemia (>1.5 mmol