UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004219 |
|---|---|
| Receipt number | R000005070 |
| Scientific Title | Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated. |
| Date of disclosure of the study information | 2010/09/16 |
| Last modified on | 2012/03/15 19:58:11 |
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Basic information
Public title
Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
Acronym
KOBE BBP(bevacizumab beyond progression) study
Scientific Title
Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
Scientific Title:Acronym
KOBE BBP(bevacizumab beyond progression) study
Region
| Japan |
Condition
Condition
Recurrent or metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line
overall response rate,
safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line in KRAS wild-type and mutant population, respectively
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
Treatment is administered every 2 weeks until evidence of progression, unacceptable toxicity or patient refusal.
During the treatment, image assessment is repeated every 2 months at least.
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
1.histologically proven unresectable metastatic colorectal cancer
2.at least one measurable leasion (CT and/or MRI, with maximum axis 20mm or more in case of 10mm slice or less, with maximum axis 10mm or more in case of 5mm slice or less)
3.refractory for oxaliplatin-based 1st line chemotherapy. Within 28 days after confirmation of disease progression in 1st line treatment.
4.KRAS status is investigated
5.age: 20-75 years old
6.ECOG PS: 0-2
7.adequate major organ functions
8.expected 3 months or over survival
9.written informed consents
Key exclusion criteria
1.clinical or radiological evidence of CNS metastases
2.current or previous (at least once within the last 1 year/ twice or more) history of arterial thromboembolism such as cerebrovascular disease
3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to enrollment/ fine-needle aspiration cytology within 7 days prior to enrollment
4.serious non-healing fracture
5.current or previous (within the last 1 year) history of GI perforation
6.evidence of bleeding diathesis, coagulopathy or abnormal coagulation factor (PT-INR>=1.5 within 14 days prior to enrollment)
7.current or recent (within 10 days prior to enrollment) ongoing treatment with anticoagulants for therapeutic purposes
8.ongoing treatment with aspirin (>= 325 mg/day), nonsteroid anti-inflammatory drug or adrenocortical steroid
9.clinically significant (i.e. active) cardiovascular disease (NCI-CTCAE grade 2 or worse), or past or current history (at least once within the last 1 year/ twice or more) of myocardial infarction
10.renal failure need to treat
11.serious complication (uncontrolled ulcer, hypertension, diabetes mellitus, infection, diarrhea,etc)
12.uncontrolled pleural effusion and/or ascites
13.past or current history (within the last 5 years) of malignant disease, except for the early cancer healed clearly
14.interstitial lung disease, or pulmonary fibrosis
15.history of organ transplantation
16.pregnancy, lactation and positive serum pregnancy test/no birth-control
17.serious drug hypersensitivity or history of drug allergy of 5-FU, l-LV and/or irinotecan
18.history of adverse reaction to fluorouracil in which DPD deficiency is suspected
19.any other cases who are regarded as inadequate for trial enrollment by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Tsuda |
Organization
Hyogo Cancer Center
Division name
Dept. of Gastrointestinal and Hepatobiliary Oncology
Zip code
Address
Kitaozi-chou 13-70, Akashi, 673-8558
TEL
078-929-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Toyoda |
Organization
Sano Hospital
Division name
Gastrointestinal Center
Zip code
Address
Shimizugaoka 2-5-1, Tarumi-ku, Kobe, 655-0031
TEL
078-785-1000
Homepage URL
masanoritoyo@hotmail.co.jp
Sponsor or person
Institute
Hyogo Cancer Center, Dept. of Gastrointestinal and Hepatobiliary Oncology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2010 | Year | 09 | Month | 16 | 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 | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 15 | Day |
Last modified on
| 2012 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005070
