UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer
Title of the study (Brief title)	Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer
Region	Japan

Condition
Condition	Unresectable colorectal cancer
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determinate maximum tolerated dose, dose-limiting toxicity and recommended dose
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	maximum tolerated dose
Key secondary outcomes	recommended dose, response rate, toxicity

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	FOLFOXIRI+Bevacizumab
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 proven colorectal cancer 2) Measurable lesions not required 3) ECOG performance status 0-2 4) without any prior chemotherapy, or with prior 5-FU, FOFLOX adjuvant therapy after 6 months of last administration 5) Adequate organ function 6) Expected >12 weeks survival 7) Written informed consent from patient 8) Age>20 or older
Key exclusion criteria	Symptomatic brain metastasis Sever wattery diarrhea Paralytic or mechanical bowel obstruction Confirmed or suspected infection Severe pulmonary disease (interstitial pneumonia, pulmonary fobrosis, severe emphysematous) Severe comorbidity (uncontrolable diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure) Pregnant or possibly pregnant, and nursing women Sever neurologic disease Receiving atazanavir sulfate Past history of monoclonal antibody allergy Past history of 5-FU/LV allergy Past history of FOLFOX allergy Complication of cerebrovascular disease or symptoms within 1 year Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week Administering antithrombotic drug within 10 days Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS) Evidence of bleeding diathesis or coagulopathy Active gastrointestinal ulcer Current or previous (within the last 1 year) history of GI perforation Non healing fracture Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction Other conditions not suitable for this study
Target sample size	20

Research contact person
Name of lead principal investigator	Ura Takashi
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL	052-762-6111
Email	tura@aichi-cc.jp

Public contact
Name of contact person	Ura Takashi
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL	052-762-6111
Homepage URL
Email	tura@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 12 Day
Anticipated trial start date	2013 Year 04 Month 03 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 08 Day
Last modified on	2018 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012210