NIPH Clinical Trials Search

JRCT ID: jRCTs061180069

Registered date:19/03/2019

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedadvanced colorectal cancer
Date of first enrollment05/10/2015
Target sample size26
Countries of recruitment
Study typeInterventional
Intervention(s)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.


Primary OutcomeRecommended dose:RD
Secondary OutcomeSafety Response rate Disease control rate: DCR Overall survival: OS

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
Include criteria1). 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/dl 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.
Exclude criteria1). 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.

Related Information


Public contact
Name Manabu Shimomura
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima 734-8551 Japan Hiroshima Japan 734-8551
Telephone +81-82-257-5222
Affiliation Hiroshima University Hospital
Scientific contact
Name Hideki Ohdan
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima 734-8551 Japan Hiroshima Japan 734-8551
Telephone +81-82-257-5222
Affiliation Hiroshima University Hospital