UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of a combination of CPT-11 and S-1 and bevacizumab in patients with metastatic colon cancer.
Title of the study (Brief title)	Phase II study of a combination of CPT-11 and S-1 and bevacizumab in patients with metastatic colon cancer.
Region	Japan

Condition
Condition	metastatic colorectal cancer
Classification by specialty	Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Response Rate Overall survial Time to Treatment Failure Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Katsuyoshi Hatakeyama
Organization	Niigata University Medical & Dental Hospital
Division name	President of a hospital
Address	754, Asahimachi-dori, Chuo-ku, Niigata City 951-8520, Niigata Prefecture, JAPAN
TEL	025-223-6161
Email

Public contact
Name of contact person	Yasumasa Takii
Organization	Niigata Cancer Center Hospital
Division name	Surgery
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

Sponsor
Institute	Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Niigata Colorectal cancer Chemotherapy Study Group
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 11 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 01 Month 14 Day
Last modified on	2019 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001963