UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005336
Receipt number R000006249
Scientific Title A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer
Date of disclosure of the study information 2011/04/01
Last modified on 2016/10/06 15:30:47

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer

Acronym

PanSIR study

Scientific Title

A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer

Scientific Title:Acronym

PanSIR study

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

valuation of efficacy and safety profile for combination therapy of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

phase I: Estimated percentage of dose-limiting toxicity at first course.
phase II: Response rate

Key secondary outcomes

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


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

S-1 80mg/m2 Oral administration day1-15 Irinotacan 150mg/m2 90min div day 1 Panitumumab 9mg/m2 90-30min div day 1
A single course to three weeks.

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) Patients who have diagnosis of colorectal cancer by pathological findings are included.
2) Patients who have unresectable advanced or incipient 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 do not have past histories of chemotherapy.
6) Patients who do not have past histories of treatment by CPT-11 and 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) UGT1A1 genetic polymorphism
11)Patients who are able to oral administration are included.
12)Patients who have adequate heart function in 28 days before registration are included.
13) 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 recieve atazanavir or flucytosin are excluded.
9) Patients who have symptomatic brain metastasis are excluded.
10) Patients who have pregnancy are excluded.
11) Patients who have heavy psycological symptoms are excluded.
12) Patients who receive steroid continuously are excluded.
13) Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded.
14) The patient that a study responsibility physician judged to be inappropriate.

Target sample size

43


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ayumu Goto 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

ayumu16g@yokohama-cu.ac.jp


Public contact

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


Sponsor or person

Institute

Department of Gastroenterological Surgery

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

横浜市立大学附属病院(神奈川県)
神奈川県立がんセンター(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The dose-limiting toxicities occurred in one patients.

Acute pancreatitis as DLT occurred in ninth patient.

The recommended dose was determined to be 9.0mg/kg of Panitumumab.

One patient had grade 3 diarrhea. None of patients had grade 3 or more severe acneiform. And two grade 3 or 4 hypomagnesemia observed.

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

2010 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date

2014 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 03 Month 29 Day

Last modified on

2016 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name