Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Department of Surgery, Jichi Medical University, Saitama Medical Center, 1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer. 2,Age greater than or equal to 20 years at the time of informed consent 3,KRAS wild type (exon2 codon12,13)determined by direct sequencing. RAS mutations in exon 3,4 are excluded. 4,ECOG performance status (PS) of 0-2 5,Written informed consent prior to study-specific screening procedure 6,Life expectancy of at least 90 days 7,Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy 8,Adequate organ function according to following laboratory values obtained within 14 days before enrollment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) i. Neutrophil count: > or = 1500/mm3 ii.Platelet count: > or = 10.0 x 104/mm3 iii.Hemoglobin: > or = 9.0 g/dL iv.Total bilirubin: < or = 1.5 mg/dL v.AST, ALT: < or =1.5100 IU/L (< or = 200 IU/I if liver metastases present) vi.Serum creatinine: < or =1.5 mg/dL
Exclusion criteria
Exclusion criteria: 1) History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection) 2) With massive pleural effusion or ascites requiring intervention 3) Radiological evidence of brain tumor or brain metastases 4) Active infection including hepatitis 5) Any of the following concurrent diseases: i. Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii. Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii. Interstitial pneumonia or pulmonary fibrosis iv. Uncontrolled diabetes mellitus v. Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy) 6) Any of the following medical history: i. Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes ii. Serious hypersensitivity to any of the study drugs iii. History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency 7) Previous treatment with irinotecan hydrochloride 8) Current treatment with atazanavir sulfate 9) Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment 10) Pregnant or lactating females, and males and females unwilling to use contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) Disease Control Rate (DCR) Overall survival (OS) Safety | — |
Countries
Japan
Contacts
Public ContactSuzuki Koichi
Jichi Medical University, Saitama Medical Center Department of Surgery
Outcome results
None listed