Colorectal cancer
Conditions
Interventions
Patients who take PPIs before the study are assigned to rabeprazole arm.
Patients who do not take PPIs before the study are assigned to control arm.
Sponsors
Showa University institute of molecular oncology Showa University School of Medicine, Division of Medical Oncology, Department of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)CapeOX and CapeOX+ Bevacizumab for metastatic colorectal cancer, CapeOX as adjuvant chemotherapy for colon cancer. 2)No history of chemotherapy within 2 weeks. 3)Eastern Cooperative Oncology Group (ECOG)performance status (PS) 0 or 1. 4)Patients with at least 3 months of life-expectancy. 5)Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy. 1.Absolute neutrophil count >= 1,500/mm3 2.Platelet count >= 75,000/mm3 3.Hemoglobin >= 9.0g/dL 4.AST and ALT <= 2 times the upper limit of normal(ULN) (<= 5 times the ULN if liver metastases are present) 5.ALP <= 2.5 times the upper limit of normal(ULN) (<= 5 times the ULN if liver metastases are present) 6.Creatinine clearance 51 mL/min or higher. (Cockcroft-Gault equation) 6)Signed, written informed concent is obtained.
Exclusion criteria
Exclusion criteria: 1)Interstitial pneumonia, pulmonary fibrosis. 2)Ongoing severe infection. 3)Prior treatment with capecitabine. 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 Carboxylesterase inducers. 11)Patients who are not appropriate to participate in the study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate Effects of rabeprazole on pharmacokinetics of capecitabine. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) To investigate association with the genetic polymorphism and the pharmacokinetics. (2) To investigate efficacy and toxicity of capecitabine in combination with PPIs. | — |
Countries
Japan
Contacts
Public ContactYutaro Kubota
Showa University School of Medicine Department of internal medicine, Division of medical oncology
Outcome results
None listed