Colorectal Cancer
Conditions
Interventions
None listed
Sponsors
Showa University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed adenocarcinoma of the colon and rectum. 2)Unresectable, locally advanced, metastatic or recurrent disease. 3)Progression after following standard therapies, which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab or panitumumab (if KRAS wild type). 4)No history of chemotherapy within 2 weeks. 5)Eastern Cooperative Oncology Group performance status of 0 to 1. 6)Measurable and evaluable disease. 7)Life expectancy of at least 3 months. 8)Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 14 days of starting to study treatment. 1.Neutrophil count 1500 /mm3 or higher. 2.Platelet count 100,000 /mm3 or higher. 3.Hemoglobin 9.0 g/dL or higher. 4.AST, ALT less than 2 times the upper limit of normal (ULN).(less than 5 times ULN for patients with liver metastasis) 5.Total bilirubin less than 1.5 times ULN. 6.ALP less than 2.5 times ULN.(less than 5 times ULN for patients with liver metastasis) 7.Serum creatinine less than 1.5 times ULN. 8.Creatinine clearance 30 mL/min or higher. (Cockcroft-Gault equation) 9)All patients were asked for written informed consent for their peripheral blood samples and medical information to be used for research purposes.
Exclusion criteria
Exclusion criteria: 1)Known history of interstitial pneumonia or pulmonary fibrosis. 2)Ongoing severe infection. 3)Prior treatment with regorafenib. 4)Unstable angina and Myocardial infarction less than 3 months before start of study drug. 5)Patients with severe complications (incontrollable diabetes mellitus or liver cirrhosis). 6)Concurrent cancer that is distinct in primary site. 7)Psychological condition that may interfere with the patient's participation in the study. 8)Pregnant patients. Men and women who want to make baby. 9)Patients with severe drug allergy or those who had severe drug allergy in the past. 10)Concomitant use of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole and clarithromycin). 11)Concomitant use of proton pump inhibitor and histamine H2-receptor antagonist. 12)Contraindication to regorafenib. 13)Patients who are not appropriate to participate in the study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics, progression free survival, response rate, adverse event, | — |
Countries
Japan
Contacts
Public ContactYutaro Kubota
Showa University School of Medicine Medical Oncology
Outcome results
None listed