UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001219 |
|---|---|
| Receipt number | 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 09:23:36 |
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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
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
colon@mhp.suita.osaka.jp
Sponsor or person
Institute
Department of Surgery, Suita Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001481
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