UMIN-CTR Clinical Trial

Public title

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab in Patients with Unresectable Metastatic Colorectal Cancer(mCRC).

Acronym

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab in Patients with Unresectable Metastatic Colorectal Cancer(mCRC).

Scientific Title

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab in Patients with Unresectable Metastatic Colorectal Cancer(mCRC).

Scientific Title:Acronym

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab in Patients with Unresectable Metastatic Colorectal Cancer(mCRC).

Region

Japan

Condition

advanced colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine a recommend dose of Lonsurf with Irinotecan and Bevacizumab in patients with unresectable metastatic colorectalcancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Recommended dose:RD

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

9

Name of lead principal investigator

1st name
Middle name
Last name	Hideki Ohdan

Organization

Hiroshima University

Division name

Gastroenterological and Transplant Surgery

Zip code

Address

1-2-3, Kasumi, Minami-ku, Hiroshima 734-8551

TEL

082-257-5222

Email

hohdan@hiroshima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomohiro Adachi

Organization

Hiroshima University

Division name

Gastroenterological and Transplant Surgery

Zip code

Address

1-2-3, Kasumi, Minami-ku, Hiroshima 734-8551

TEL

082-257-5222

Homepage URL

Email

adachitomohiro@hotmail.com

Institute

Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広島大学病院（広島県）

Date of disclosure of the study information

2015

Year

09

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015

Year

09

Month

16

Day

Date of IRB

Anticipated trial start date

2015

Year

09

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

14

Day

Last modified on

2018

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021907