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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009362
Receipt No. R000011002
Scientific Title Phase I trial of combined chemotherapy of bevacizumab, panitumumab and irinotecan as 3rd-line chemotherapy in chmotherapy-refractory metastatic colorectal cancer.
Date of disclosure of the study information 2012/11/26
Last modified on 2016/11/22

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Basic information
Public title Phase I trial of combined chemotherapy of bevacizumab, panitumumab and irinotecan as 3rd-line chemotherapy in chmotherapy-refractory metastatic colorectal cancer.
Acronym Phase I trial of combined chemotherapy of bevacizumab, panitumumab and irinotecan as 3rd-line chemotherapy in chmotherapy-refractory metastatic colorectal cancer.
Scientific Title Phase I trial of combined chemotherapy of bevacizumab, panitumumab and irinotecan as 3rd-line chemotherapy in chmotherapy-refractory metastatic colorectal cancer.
Scientific Title:Acronym Phase I trial of combined chemotherapy of bevacizumab, panitumumab and irinotecan as 3rd-line chemotherapy in chmotherapy-refractory metastatic colorectal cancer.
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety profile and determine the recommend dose of combined chemotherapy of bevacizumab, panitumumab and irinotecan as 3rd-line chemotherapy in patitents with metastatic colorectal cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Proportion of dose limiting toxicity (DLT).
Key secondary outcomes Clinical effect of chemotherapy, proportion of adverse events, PK and biomarkers

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 Combined chemotherapy of bevacizumab, panitumumab, irinotecan.
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)adenocarcinoma of colorectalcancer
2)KRAS wild type
3)histrogical type:adenocarcinoma(tub1, tub2, por), mucinous adenocarcinoma, signet cell carcinoma
4)Age;20 to 75 years old
5)ECOG PS;0 or 1
6)Survival time above 3 months are expected after registration to clinical trial
7)target lesion or non-target lesion by RECIST ver 1.1
8)3rd line chemotherapy and previous use of bevacizumab.
9)refractory or intolerance for fluoropyrimidine, L-OHP, irinotecan as previous chemotherapy
10)Adecuate organ function (laboratory data)
11)Patients could register this trial after 4weeks of surgery, 4weeks after radiation therapy, 2weeks of chemotherapy.
12)consent form of patients
Key exclusion criteria 1) Double advenced cancer
2) Past history of severe allergy of drugs
3) Active infection
4) Severe complication such as paresis of intestine, ileus, intestinal pneumonia, uncontrollable DM, cardiac disease, uncontrolled hypertension, thrombosis, renal failure, liver failure
5) Previous use of anti-EGFR antibodies
6) Uncontorollable pleural effusion and acites
7) Asymptomatic brain metastasis
8) Active bleeding of intestine
9) Uncontrollable diarrhea
10) Female with pregnancy
11) Inappropriate patients for clinical trial that are judged by doctors
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhide Yamada
Organization National Cancer Center Hospital, Tokyo, Japan.
Division name Gastrointestinal Onclogy Division
Zip code
Address 5-1-1, Tukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email yayamada@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Takahashi
Organization National Cancer Center Hospital, Tokyo, Japan.
Division name Gastrointestinal Onclogy Division
Zip code
Address 5-1-1, Tukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email naoki19800623@gmail.com

Sponsor
Institute National Cancer Center Hospital, Tokyo, Japan.
Institute
Department

Funding Source
Organization Princess Takamatsu Cancer Reseach fund
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 国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 19 Day
Last modified on
2016 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011002

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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