advanced colorectal cancer
Conditions
Interventions
1 cycle is 28days. Lonsurf(25mg/m2)is administered orally twice daily in 1-5days and 8-12 days. Irinotecan(100mg/m2) and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15.
Sponsors
Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1). Written informed consent 2). >=20 years old and <=75 years old 3). Histologically or cytologically proven adenocarcinoma of colon or rectum, and KRAS test and UGT1A1 wild type were carried out. 4). Unresectable metastatic colorectal cancer. 5). ECOG Performance Status of 0 or 1 6). Adequate oral intake 7). With evaluable disease according to RECIST. 8). Organ functions are secured for less than 14 days before registration by inspection of a. Hemoglobin >=9.0 g/d b. Absolute neutrophil count>= 1,500 /mm3 c. Platelet count >=75,000 /mm3 d. Total bilirubin <=1.5 mg/dl e. AST and ALT <= 100 IU/L f. Serum creatinine <= 1.5mg/dL 9). Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.Patients who do have intention that uses effective contraception method until 1 month after administering investigational drug. 10). Patient is willing or able to comply with protocol.
Exclusion criteria
Exclusion criteria: 1). Prior treatment with Lonsurf. 2). It is a case with the past of hypersensitivity for Bevacizumab. 3). Hemoptysis with the past. 4). It is a case with the Contraindication for receiving Irinotecan. 5). Serious coexisting illness as follows. a. Active double cancer(s) b. CNS metastasis c. Uncontrollable infection disease d. Uncontrollable pleural effusion, ascites, or cardiac effusion e. Ileus, interstitial pneumonia, renal failure, hepatic failure or cerebrovascular disorder f. Uncontrolled diabetic g. Uncontrolled hypertension h. Uncontrolled diarrhea or jaundice i. Cardiac infarction, serious angina or New York Heart Association Class III or IV within 12 months prior to the registration k. Gastrointestinal bleeding l. Positive HBs antigen, HCV antibody or HIV antibody m. Need immunosuppressive therapy n. Uncontrolled mental disease or the psychotic manifestation. 6). Receive the treatment as follows. a. Major surgery therapy within 4 weeks prior to enrollment. b. Wide filed radiotherapy 4 weeks prior to enrollement or local radiotherapy 2 weeks prior to enrollment. c. Other investigational drugs within 4 weeks prior to enrollment. 7). Blood transfusion or G-CSF within 14 days prior to enrollment. 8). Serious renal failure or proteinuria >= 2+ within 7 days prior to enrollment. 9). increase of >= 7 stools/day or incontinence. 10). Thromboembolic event or serious Pulmonary complaints within 6 months 11). Incomplete cure wound or traumatic fracture 12). Tendency to hemorrhages or taking antithrombotic medication 13). Women during pregnancy or lactation 14). Patients is judged by the investigator to be inappropriate for study participation for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended dose:RD | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Response rate Disease control rate: DCR Overall survival: OS | — |
Countries
Japan
Contacts
Public ContactTomohiro Adachi
Hiroshima University Gastroenterological and Transplant Surgery
Outcome results
None listed