malignant solid tumor (pancreatic cancer, colorectal cancer, gastric cancer, lung cancer, ovarian cancer,breast cancer, neuroendocrine carcinoma)
Conditions
Interventions
None listed
Sponsors
Showa university school of medicine
Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 20 to <75 years at the time of informed consent. 2) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 3) Patients who was not treated with the irinotecan hydrochloride in the past. 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. Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 Hemoglobin >= 8.5g/dL AST and ALT <= 2.5 times the upper limit of normal(ULN) (<= 5 times the ULN if liver metastases are present) Total bilirubin <= 1.5 times the ULN 6) Signed, written informed concent is obtained.
Exclusion criteria
Exclusion criteria: 1) Severe active infection. 2) Sever diarrhea. 3) Gastrointestinal paresthesia and bowel obstruction. 4) Interstitial pneumonia, pulmonary fibrosis. 5) Jaundice. 6) Patient who need drainage of peritoneal, pleural or pericardial effusion. 7) Unstable angina, myocardial infarction or heart failure within 3 months. 8) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease). 9) Serological positive for HBs-antigen or HCV-antibody. 10) Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollment. 11) Patients who received chemotherapy not to include irinotecan hydrochloride, or radiation therapy within two weeks. 12) Severe hypersensitivity to medicine. 13) Patients who has difficulty in getting the understanding for the study. 14) Pregnant or lactating women, or men and women without wanting pregnancy. 15) Patients who were judged inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We analyze genetic polymorphism of OATP1B1, ABCG2 and OATP2B1 and Pharmacokinetics/Pharmacodynamics of the irinotecan and metabolite and toxicity expression relations of the irinotecan hydrochloride. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) We analyze about genetic polymorphism(OATP1B3, ABCB1, ABCC2 and CES2 which participates in activation of irinotecan, CYP3A4 which participates in inactivation of irinotecan) and a relation between PK/PD and toxicity. (2) We analyze the genetic seasonal polymorphism to encode microRNA (miRNA) and the genetic polymorphism of an enzyme participating in processing of miRNA and PK/PD of the irinotecan hydrochloride and relations with the toxicity. (3) We measure the plasma concentration of an internal compound becoming the OATP substrate and evaluate OATP inhibition by SN-38 and get grounds to estimate the interaction risk between the drug in the irinotecan hydrochloride dosage. (4) We perform meta genome analysis of the enterobacterial flora and analyze a relation between toxicity of irinotecan hydrochloride (including the diarrhea) and enterobacterial flora. | — |
Countries
Japan
Contacts
Public ContactYutaro Kubota
Showa university school of medicine Department of internal medicine, Division of medical oncology
Outcome results
None listed