UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of combined chemotherapy of bevacizumab, panitumumab and irinotecan as 3rd-line chemotherapy in chmotherapy-refractory metastatic colorectal cancer.
Title of the study (Brief title)	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	Yasuhide Yamada
Organization	National Cancer Center Hospital, Tokyo, Japan.
Division name	Gastrointestinal Onclogy Division
Address	5-1-1, Tukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	yayamada@ncc.go.jp

Public contact
Name of contact person	Naoki Takahashi
Organization	National Cancer Center Hospital, Tokyo, Japan.
Division name	Gastrointestinal Onclogy Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011002