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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002407
Receipt No. R000002944
Scientific Title Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy
Date of disclosure of the study information 2009/09/01
Last modified on 2013/06/27

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Basic information
Public title Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy
Acronym Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy
Scientific Title Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy
Scientific Title:Acronym Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the efficacy and safety of Bevacizumab(10mg/kg) in combination with FOLFIRI as second-line therapy after progression on Bevacizumab with Oxaliplatin-based chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Safety,Overall response rate,Overall survival,Overall survival from 1st line

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bevacizumab(10mg/kg) plus FOLFIRI
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histological confirmation of colorectal cancer
2.Measurable lesion
3.documented disease progression(PD) during Bevacizumab with Oxaliplatin-based chemotherapy* or within four weeks thereafter via radiographic assessment *receipt of this regimen for at least two months
4.Age : > 20 years
5.ECOG-PS : 0-2
6.Adequate organ function before fourteen days,defined as leukocyte count >= 3000/mm3(neutrophil cell count >=1500/mm3),platelet count >= 100000/mm3,hemoglobin >=9.0g/dl,Total bilirubin <= 1.5xULN,AST/ALT/ALP <= 2.5xULN,serum creatinine <= 1.5xULN

7.Survival period more than 3 months
8.Written informed consents
Key exclusion criteria 1.clinical or radiological evidence of CNS metastases.
2.current or previous (within the last 1 year) history of cerebrovascular disease
3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to Day 0
4.serious non-healing fracture
5.current or previous (within the last 1 year) history of GI perforation
6.serious non-healing ulcer
7.evidence of bleeding diathesis or coagulopathy.
8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes
9.ongoing treatment with aspirin (> 325 mg/day)
10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
11.uncontrolled hypertension
12. serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment
13.uncontrolled pleural and/or peritoneal effusion
14.past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated:
- Basal and squamous cell carcinoma of the skin
- In-situ carcinoma of the cervix
15.interstitial lung disease, or pulmonary fibrosis
16.uncontrolled infection
17.history of organ transplantation
18.diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3.
19.pregnancy (positive serum pregnancy test) and lactation
20.serious drug hypersensitivity or a history of drug allergy
21.history of adverse events related to fluorouracil
22.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name michio nakamura
Organization Sapporo City General Hospital
Division name Divison of Gastrointestinal Oncology and Endoscopy
Zip code
Address KITA-11 NISHI-13-1-1,CHUO-KU,SAPPORO,060-8604,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name michio nakamura
Organization Sapporo City General Hospital
Division name Divison of Gastrointestinal Oncology and Endoscopy
Zip code
Address KITA-11 NISHI-13-1-1,CHUO-KU,SAPPORO,060-8604,Japan
TEL
Homepage URL
Email

Sponsor
Institute Sapporo City General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 市立札幌病院(北海道)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 01 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 Terminated
Date of protocol fixation
2009 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2013 Year 07 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
2009 Year 08 Month 31 Day
Last modified on
2013 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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