Colorectal cancer
Conditions
Interventions
Start with regorafenib 120mg/day, and escalate the dosage to 160mg/day if compatible with the criteria at day 15
Sponsors
Keio university hospital Cancer center Internal medecine Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological documentation of adenocarcinoma of the colon or rectum 2)Unresectable due to metastasis or advanced disease 3)At least measurable disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1-1 4)Progression during or within 3 months following the last administration of approved standard therapies, which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab or panitumumab (if KRAS wild type). Patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent before progression of disease will also be allowed into the study. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. Usage of TAS-102 does not matter. 5)Life expectancy of at least 3 months 6)Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment. 1.absolute neutrophil count >=1500/mm3 2.Hemoglobin >=9g/dl 3.Platelet count >=100 000/mm3 4.Total bilirubin =<1.8mg/dl 5.Alanine aminotransferase and aspartate aminotransferase =<100IU/L (=<200IU/L for patients with liver involvement of their cancer) 6.Serum creatinine =<1.5mg/dl 7.Alkaline phosphatase =<700IU/L(=<1400 for patients with liver involvement of their cancer) 8.PT-INR=<1.8(therapeutic range for patients with anticoagulants) 7)Eastern Cooperative Oncology Group performance status of =<1 8)Male or female patients >=18 years of age 9)Signed informed consent with adequate explanation obtained
Exclusion criteria
Exclusion criteria: 1)Prior treatment with regorafenib 2)Congestive heart failure of New York Heart Association class 2 or worse 3)Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug. 4)Uncontrolled hypertension 5)Pleural effusion or ascites which cause dyspnea 6)Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication. 7)Hepatitis B or C with antivirus therapy 8)Known history of human immunodeficiency virus infection 9)Symptomatic metastatic brain tumor 10)Any haemorrhage or bleeding event of CTCAE grade 3 or higher within 4 weeks of start of study medication. 11)Interstitial lung disease with ongoing signs and symptoms 12)Persistent proteinuria of CTCAE grade 3 or higher 13)Inability to swallow oral medications 14)Non-healing wound, ulcer, or bone fracture 15)Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure, excluding alopecia and oxaliplatin-induced neurotoxicity 16)Double cancer, which includes simultaneous double cancer and metachronous double cancer of which desease-free intarval is within five years and does not include carcinoma in situ and intramucosal cancer which can be cured by local treatment. 17)Judged as inappropriate by attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Desease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Resopnse rate, Progression free survival, Overall survival, Adverse event, Completion rate of 2 cycles, Dosage of 3rd cycle, Rate of patients with dose escalation, Pharmacokinetics | — |
Countries
Japan
Contacts
Public ContactTakeshi Suzuki
Keio university hospital Internal medecine(Gastroenterology)
Outcome results
None listed