UMIN-CTR Clinical Trial

Public title

Phase II study of a combination of CPT-11 and S-1 and bevacizumab in patients with metastatic colon cancer.

Acronym

Phase II study of a combination of CPT-11 and S-1 and bevacizumab in patients with metastatic colon cancer.

Scientific Title

Phase II study of a combination of CPT-11 and S-1 and bevacizumab in patients with metastatic colon cancer.

Scientific Title:Acronym

Phase II study of a combination of CPT-11 and S-1 and bevacizumab in patients with metastatic colon cancer.

Region

Japan

Condition

metastatic colorectal cancer

Classification by specialty

Hematology and clinical oncology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The primary objective of this study was to explore the progression free survival (PFS), antitumor effect (response rate), overall survival (OS), time to treatment failure (TTF) and safety of these three drugs, which combined chemotherapy with CPT-11, S-1 and bevacizumab in patients with metastatic colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression Free Survival

Key secondary outcomes

Response Rate
Overall survial
Time to Treatment Failure
Safety

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

We use three drugs (CPT-11, S-1, bevacizumab) for this trial. The treatment schedule of CPT-11 and bevacizumab are administrated on day 1 and day 15, and of S-1 is administrated between day1 and day 21. The dosage of CPT-11 are 75 mg/m2, and of S-1 are 65 mg (the dosage are calculated by body surface area), and of bevacizumab are 10 mg/kg.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

The eligibility criteria were as follows:1)2)3) histologically proven unresectable metastatic colorectal adenocarcinoma with assessable lesions; 4) previous first line chemotherapy containing oxaliplatine, and was progression disease or treatment failure; 5) at least 2 weeks must have elapsed since any prior chemotherapy; 6) prior radiation therapy are not done; 7) age 20-80 years patients; 8) Eastern Cooperative Oncology performance status (PS) 0-1; 9) survival period more than 3 months; 10) adequate organ function before fourteen days, defined as leukocyte count >4000-12000/mm3, platelet count >100000/mm3, neutrophil cell count >2000/mm3, hemoglobin >9.0 g/dl, serum transaminase (aspartate aminotransferase and alanine aminotransferase) <100/UI (in case of hepatic metastatic patients are at a physician's discretion), serum bilirubin level <1.5mg/dl, serum creatinine level <1.2mg/dl, estimated creatinine clearance level > 50ml/min (in case of woman, the value is 0.85 times); 9) the patients who can take oral drugs; 10) patients determined by electrocardiography within 28 days before entry, and allowed to enroll this trial by primary doctor; 11) and written informed consent from the patients; 12) the patients can eat
This study was approved by the ethics committees in each institution.

Key exclusion criteria

The exclusion criteria were as follows; patients were not eligible for this study if; 1) they had undergone treatment with CPT-11 chemotherapy prior to this study, 2) had active double cancer; 3) had active infection disease (over 38.0C fever); 4) had gastrointestinal paralysis, bowel blockage or history within 1 year before entry; 5) had serious interstitial lung disease and lung fibrosis; 6) had water solubility diarrhea; 7) had diabetes mellitus which could not be controlled; 8) had hypertension which could not control with drug therapy; 9) had proteinuria > 2 plus 10) had serious complication (e.g. heart failure, hepatic failure, kidney failure); 11) had comorbid disease of cerebral vascular disorder or history within 1 year before entry; 12) were operated or performed dissected biopsy within 4 weeks before entry; 13) were bleeding tendency, coagulation disorder, abnormality of coagulation factor (INR>1.5) within 2 weeks before entry; 14) were administered antithrombotic within 10 days before entry; 15) were administered antiplatelet agent for chronic rheumatoid arthritis; 16) were administred flucytosine or atazanavir ; 17) were systemically-administered of steroids
; 18) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant ; 19) had a previous serious medical illness or allergy for drugs ; 20) had brain metastasis or had treated for brain metastasis ; 21) had myelosuppression ; 22) had pleural effusion or abdominal dropsy which need therapy ; 23) had jaundice ; 24) except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Katsuyoshi Hatakeyama

Organization

Niigata University Medical & Dental Hospital

Division name

President of a hospital

Zip code

Address

754, Asahimachi-dori, Chuo-ku, Niigata City 951-8520, Niigata Prefecture, JAPAN

TEL

025-223-6161

Email

Name of contact person

1st name
Middle name
Last name	Yasumasa Takii

Organization

Niigata Cancer Center Hospital

Division name

Surgery

Zip code

Address

2-15-3, Kawagishi-chou, Chuo-ku, Niigata City 951-8520, Niigata Prefecture, JAPAN

TEL

025-266-5111

Homepage URL

Email

takii@niigata-cc.jp

Institute

Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Niigata Colorectal cancer Chemotherapy Study Group

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

Date of disclosure of the study information

2009

Year

01

Month

14

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2008

Year

11

Month

26

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

2013

Year

01

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

01

Month

14

Day

Last modified on

2019

Year

02

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001963