UMIN-CTR Clinical Trial

Public title

Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer

Acronym

Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer

Scientific Title

Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer

Scientific Title:Acronym

Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer

Region

Japan

Condition

Advanced/Recurrent Colorectal Cancer

Classification by specialty

Gastroenterology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of cetuximab and S-1 combinaton therapy in patients with metastatic colorectal cancer.

Basic objectives2

Others

Basic objectives -Others

pharmacokinetics,time to success treatment, overall survival,tumor response, quality of life

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

To determine the recomend dose of cetuximab and S-1 combinaton therapy

Key secondary outcomes

pharmacokinetics(PK/PD), a time to success treatment, overall survival, tumor response, quality of life

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

cetuximab S-1 combination therapy
cetuximab : Weekly administration 400 mg/m2 for the 1st time (day1), 250mg/m2/week for the 2nd time or another (day8,15,..)
S-1 : 60 or 80 mg/m2/2weeks/day1-14, 4weeks

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Patients with histologically proven colorectal cancer, and Unresectable or recurrent colorectal camcer
patient who treatment of pallitive radiation can enroll to time that radiaton ended 1 week
(2)EGFR protein detected by tumor sample
(3)Patient was not treated to cetuximab
(4)Age >= 20 and =< 75.
(5)ECOG performance status of 0,1,and 2.
(6)Patient can be oral ingestion.
(7) Unresectable primary tumor or with one or more unresectable metatatic tumor
Measurable or evaluable disease (measurable lesions in RECIST criteria is unnecessary) within 30 days before registration.
(8)Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration.
(9)Resistrar evaluation patients who survive 12 weeks.
(10)Patient can be contraception time to therapy ended 3 months.
(11)Patient was explain of this trial and put patient's signature to a document.

Key exclusion criteria

(1)A case with the interstitial pneumonia that is clear by chest CT or pulmonary fibrosis.
(2)A case receiving flucytosine (a pyrimidine system antifungal agent fluoride).
(3)A case with a history of serious drug allergy.
(4)The case with pleural effusion, ascitic fluid needing treatment such as the drainage and the pericardial fluid.
(5) The case with serious heart disorder, myocardial infarction within six months, hypertension having poor control, bacterial infection and fungal infection of the activity and other serious complications (haemorrhage of digestive tract).
(6)A case to have a short bowel syndrome merger or diarrhea (watery feces) continuously.
(7) Intestinal paralysis, a case with bowel obstruction.
(8) Metastases to brain case with the symptom.A case (as for the metastases to brain case that a symptom was stable by metastases to brain case and radiotherapy and medical treatment without the symptom, possible registration) to need the antihydropic including the steroid of the symptom control purpose.
(9)A case with the diabetes mellitus inadequate control.
(10)The case that it was judged mental disorder to become the clinical problem to have difficulty in registration to this study.
(11)A case to have pregnant or pregnant possibilities, the case that there is not of the intention to prevent conception and the case that we are nursing.
(12)In addition, the case that we judged to be inadequate though the medical attendants conducted this study

Target sample size

21

Name of lead principal investigator

1st name
Middle name
Last name	Soichi Fumita

Organization

Kinki university school of medicine

Division name

Department of clinical oncology

Zip code

Address

377-1,Onohiasi, Osakasayama-city, Osaka

TEL

072-366-0221

Email

Name of contact person

1st name
Middle name
Last name	Soichi Fumita

Organization

Kinki university school of medicine

Division name

Department of clinical oncology

Zip code

Address

377-1,Onohiasi, Osakasayama-city, Osaka

TEL

072-366-0221

Homepage URL

Email

Institute

Kinki university school of medicine
Department of clinical oncology

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

近畿大学医学部附属病院

Date of disclosure of the study information

2010

Year

08

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2010

Year

01

Month

15

Day

Date of IRB

Anticipated trial start date

2010

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

08

Month

30

Day

Last modified on

2010

Year

08

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004953