UMIN-CTR Clinical Trial

Public title

A phase II study of panitumumab for refractory pateients to standard treatments with KRAS wild type advenced colorectal cancer

Acronym

A phase II study of panitumumab for patients with KRAS wild type colorectal cancer

Scientific Title

A phase II study of panitumumab for refractory pateients to standard treatments with KRAS wild type advenced colorectal cancer

Scientific Title:Acronym

A phase II study of panitumumab for patients with KRAS wild type colorectal cancer

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Evaluation of efficacy and safety profile for treatment of panitumumab for KRAS wild typed colorectal cancer patients who were refractory to satandard regimens

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

frequency of Adverse events
tumor regression rate
Progression-free survival
Overall survival
Treatment completion rate
Time to treatment failure

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who have diagnosis of colorectal cancer by pathological findings are included.
2) Patients who have unresectable advanced or recurrent cancer are included.
3) Patients who have cancer with KRAS wild type are included.
4) Patients who have measurable lesions are included.
5) Patients who have past histories of treatment failures by fluoropyrimidines, irinotecan and oxaliplatin are included.
6) Patients who do not have past histories of treatment by panitumumab or cetuximab are included.
7) Patients who are over 20 year old and would expect survival over 3 months after registration are included.
8) Patients who are under 2 ECOG performance status are included.
9) Patients who have adequate bone marrow and organ functions are included.
10) Patients who have adequate heart function in 28 days before registration are included.
11) Patients who are written informed consent are included.

Key exclusion criteria

1) Patients who have allergy for drugs are excluded.
2) Patients who have other malignancies are excluded.
3) Patients who have infections in active are excluded.
4) Patients who have past histories of bowel perforation and / or bowel obstruction in one year before registration are excluded.
5) Patients who have severe diseases are excluded.
6) Patients who have pleural effusion and / or ascites to need treatment are excluded.
7) Patients who have watery diarrhea are excluded.
8) Patients who have symptomatic brain metastasis are excluded.
9) Patients who have pregnancy are excluded.
10) Patients who receive steroid continuously are excluded.
11) Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded.
12) Patients whom physicians decide to exclude are ineligible.
13) The patient that a study responsibility physician judged to be inappropriate.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Itaru Endo, MD. PhD.

Organization

Yokohama City University Hospital

Division name

Department of Gastroenterological Surgery

Zip code

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2800

Email

endoit@med.yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Ayumu Goto MD. PhD.

Organization

Yokohama City University Hospital

Division name

Clinical Oncology division

Zip code

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2800

Homepage URL

Email

ayumu16g@yokohama-cu.ac.jp

Institute

Department of Gastroenterological Surgery

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立市民病院（神奈川県）
藤沢市民病院（神奈川県）
横須賀共済病院（神奈川県）
済生会横浜市南部病院（神奈川県）
横浜市立みなと赤十字病院（神奈川県）
横浜掖済会病院（神奈川県）
済生会若草病院（神奈川県）
国立病院機構横浜医療センター（神奈川県）
横浜船員保険病院（神奈川県）

Date of disclosure of the study information

2010

Year

12

Month

02

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results of this study demonstrate that tri-weekly panitumumab treatment is a promising regimen offering benefits in terms of convenience and safety in patients with advanced colorectal cancer

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

Recruitment status

Completed

Date of protocol fixation

2010

Year

11

Month

11

Day

Date of IRB

Anticipated trial start date

2010

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Either of the following treatment methods are selected.
1) panitumumab(6mg/kg) day 1,q2w until disease progression
2) panitumumab(9mg/kg) day 1,q3w until disease progression
3) panitumumab(6mg/kg) plus FOLFOX day 1,q2w until disease progression
4) panitumumab(6mg/kg) plus FOFIRI day 1,q2w until disease progression
5) panitumumab(6mg/kg) plus CPT-11 day 1,q2w until disease progression

Registered date

2010

Year

12

Month

02

Day

Last modified on

2018

Year

12

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005545