UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001219
Receipt No. R000001481
Scientific Title Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer
Date of disclosure of the study information 2008/06/30
Last modified on 2009/01/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer
Acronym Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer
Scientific Title Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer
Scientific Title:Acronym Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study was to explore the dose limiting toxicity (DLT), the maximum tolerated dose (MTD) and recommended dose (RD), which combined chemotherapy with CPT-11, TS-1 and bevacizumab in patients with metastatic colorectal cancer. The secondary objective of this study was to explore the antitumor effect (response rate), overall survival (OS) and progression free survival (PFS) of these three drugs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes safety
Key secondary outcomes efficacy

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, TS-1, bevacizumab) for this trial. The treatment schedule of CPT-11 and bevacizumab are administrated on day 1 and day 15, and of TS-1 is administrated between day1 and day 21. The dosage of CPT-11 are 80-110/m2, and of TS-1 are 80-120mg (the dosage are calculated by body surface area), and of bevacizumab are 5 or 7mg/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
75 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)prior chemotherapy are not defined, except bevacizumab or CPT-11 chemotherapy
prior to this study; 5)prior radiation therapy are not done; 6)age 20-75 years patients who are expected survival period more than 3 months; 7)Eastern Cooperative Oncology performance status (PS) 0-1; 8)adequate organ function before fourteen days, defined as hemoglobin >9.0 g/dl, leukocyte count >3500-12000/mm3, neutrophil cell count >1500/mm3, platelet count >100000/mm3, serum bilirubin level <1.5mg/dl, serum transaminase (aspartate aminotransferase and alanine aminotransferase) <100/UI, (in case of hepatic metastatic patients are <150/UI), 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. Patients with symptomatic brain metastases were not eligible. 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 they had a previous serious medical illness or allergy for drugs; had active double cancer; had active infection disease (over 38.0C fever); had perforation of the digestive tract, gastrointestinal paralysis, bowel blockage or history within 1 year before entry; had hypertension which could not control with drug therapy; had serious complication (e.g. interstitial lung disease, lung fibrosis, heart failure, kidney failure, hepatic failure, diabetes mellitus which could not be controlled); had pleural effusion or abdominal dropsy which need therapy; had water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity; took flucytosine or atazanavir; had brain metastasis; were pregnancy or lactation; could not joint this trial because of mental disorder or psychiatric symptom; were systemically-administered of steroids; were uric protein greater than 2 positive ; were thrombosis; were brain infarction, myocardial infarction or lung infarction before entry; were operated or performed dissected biopsy within 4 weeks before entry; were administered antiplatelet agent for chronic rheumatoid arthritis; were bleeding tendency, coagulation disorder, abnormality of coagulation factor, or administered anticoagulant; 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 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Murata
Organization Suita Municipal Hospital
Division name Surgery
Zip code
Address 2-13-20 Katayama-cho, Suita, Osaka, Japan
TEL 06-6387-3311
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Murata
Organization Suita Municipal Hospital
Division name Surgery
Zip code
Address
TEL 06-6387-3311
Homepage URL
Email colon@mhp.suita.osaka.jp

Sponsor
Institute Department of Surgery, Suita Municipal Hospital
Institute
Department

Funding Source
Organization Osaka Cancer Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status
Date of protocol fixation
2008 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 06 Month 30 Day
Last modified on
2009 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.