Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab

JRCT ID: jRCTs061180069

Registered date:19/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: advanced colorectal cancer
• Date of first enrollment: 05/10/2015
• Target sample size: 26
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Recommended dose:RD

Secondary Outcome

Safety
Response rate
Disease control rate: DCR
Overall survival: OS

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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/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 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.

Related Information

• Primary Sponsor: Ohdan Hideki
• Secondary ID(s): UMIN000019004