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

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 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


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

Value
https://center6.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