Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Department of clinical pharmacokinetics, Graduate school of Pharmaceutical Science, Kyushu University
Department of Hematology and Oncology, Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed colorectal cancer 2) Patient who is intended to receive chemotherapy with continuously infused 5-fluorouracil 3)20 years of age or older 4)Performance Status (ECOG) 0-2 5)Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows; WBC count >= 3,000 /mm3 absolute neutrophil count >= 1,500 /mm3 platelet count >= 100,000 /mm3 hemoglobin >= 7.0 g/dL AST/ALT/ALP <= 2.5 X institutional upper limit of normal Total bilirubin less than or equal to 2.0 mg/dL serum creatinine within 2.0 times the upper limit of normal 6) Signed informed consent
Exclusion criteria
Exclusion criteria: 1) Hoped to be pregnant/nursing. 2) Allergy to fluoropyrimidine compounds 3) Simultaneous use of other fluoropyrimidine drugs 4) History of severe complicating disease 5) Active infection 6) History of bone-marrow transplantation 7) Those who received a white blood cell transfusion within 30 days before registration 8) Those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the relationship between 5-FU pharmacokinetics and plasma biomarkers. | — |
Countries
Japan
Contacts
Public ContactYoshimasa Shiraishi
Graduate school of Pharmaceutical Science, Kyushu University Department of clinical pharmacokinetics
Outcome results
None listed