UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009362 |
|---|---|
| Receipt number | 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 18:24:21 |
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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
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
naoki19800623@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital, Tokyo, Japan.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011002
