colorectal cancer
Conditions
Interventions
S-1 80mg/m2 Oral administration day1-15 Irinotacan 150mg/m2 90min div day 1 Panitumumab 9mg/m2 90-30min div day 1 A single course to three weeks.
Sponsors
Department of Gastroenterological Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have diagnosis of colorectal cancer by pathological findings are included. 2) Patients who have unresectable advanced or incipient or recurrent cancer are included. 3) Patients who have cancer with KRAS wild type are included. 4) Patients who have measurable lesions are included. 5) Patients who do not have past histories of chemotherapy. 6) Patients who do not have past histories of treatment by CPT-11 and panitumumab or cetuximab are included. 7) Patients who are over 20 year old and would expect survival over 3 months after registration are included. 8) Patients who are under 2 ECOG performance status are included. 9) Patients who have adequate bone marrow and organ functions are included. 10) UGT1A1 genetic polymorphism 11)Patients who are able to oral administration are included. 12)Patients who have adequate heart function in 28 days before registration are included. 13) Patients who are written informed consent are included.
Exclusion criteria
Exclusion criteria: 1) Patients who have allergy for drugs are excluded. 2) Patients who have other malignancies are excluded. 3) Patients who have infections in active are excluded. 4) Patients who have past histories of bowel perforation and / or bowel obstruction in one year before registration are excluded. 5) Patients who have severe diseases are excluded. 6) Patients who have pleural effusion and / or ascites to need treatment are excluded. 7) Patients who have watery diarrhea are excluded. 8) Patients who recieve atazanavir or flucytosin are excluded. 9) Patients who have symptomatic brain metastasis are excluded. 10) Patients who have pregnancy are excluded. 11) Patients who have heavy psycological symptoms are excluded. 12) Patients who receive steroid continuously are excluded. 13) Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded. 14) The patient that a study responsibility physician judged to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| phase I: Estimated percentage of dose-limiting toxicity at first course. phase II: Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| frequency of Adverse events Progression-free survival Overall survival Treatment completion rate Time to treatment failure | — |
Countries
Japan
Contacts
Public ContactAyumu Goto MD. PhD.
Yokohama City University Hospital Clinical Oncology division
Outcome results
None listed