UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011863 |
|---|---|
| Receipt number | R000013867 |
| Scientific Title | Phase I/II study of Paclitaxel+Trastuzumab therapy in 2nd line treatment for advanced or recurrent gastric cancer with HER2 positive. |
| Date of disclosure of the study information | 2013/09/25 |
| Last modified on | 2017/09/27 10:59:22 |
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Basic information
Public title
Phase I/II study of Paclitaxel+Trastuzumab therapy in 2nd line treatment for advanced or recurrent gastric cancer with HER2 positive.
Acronym
PTX+Tmab(2nd)
Scientific Title
Phase I/II study of Paclitaxel+Trastuzumab therapy in 2nd line treatment for advanced or recurrent gastric cancer with HER2 positive.
Scientific Title:Acronym
PTX+Tmab(2nd)
Region
| Japan |
Condition
Condition
HER2-positive gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of paclitaxel+trastuzumab combination chemotherapy on HER2-posistive advanced or recurrent gastric cancer refractory to fluoropyrimidine and platinum.
Phase I:To know the feasibility and recommended dose of Paclitaxel+Trastuzumab.
Phase II:The effectiveness and feasibility by recommended dose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I:Maximum tolerated dose and recommended dose
Phase II:Response Rate(RR)
Key secondary outcomes
Phase I:Response Rate (RR), Incidence and degree of adverse events
Phase II:Progression free survival (PFS), Overall survival (OS), Incidence of adverse events
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
Trastuzumab:8mg/kg(i.v.) for the initial dosing and 6mg/kg for subsequent administration. Trastuzumab administered at day 1.
Paclitaxel:80-100mg/m2 administered at day 1 and day 8.
One course lasts 3 weeks (21 days)
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 confirmed adenocarcinoma; papillary, tubular, poorly, signet ring cell, mucinous, or hepatoid
2)Unresectable advanced or recurrent gastric cancer
3)with measurable lesions
4)Able or unable to eat or drink
5)Age over 20 years old and under 80
6)PS(ECOG) between 0 and 1
7)HER2 positive
8)No previous chemotherapy of Paclitaxel
9)Without any brain metastasis
10)With a good condition of important organs within 14 days of registration
a)Neutrophil>=2,000/mm3
b)Platelet>=100,000/mm3
c)Total bilirubin<=1.5mg/dL
d)Hemoglobin>=8.0g/dL
e)AST<=100IU/L, or AST<=200IU/L with liver metastases
f)ALT<=100IU/L, or ALT<=200IU/L with liver metastases
g)Serum creatinine<=1.2mg/dL
11)Written informed consent to participate in this study
Key exclusion criteria
1)With active double cancers whose disease free period is within 5 years. Carcinoma in situ can be excluded.
2)With a history of severe allergy against medicine.
3)With severe diarrhea (more than 4 times/day) or watery stool
4)With body temperature over 38 degrees Celsius and/or infectious disease which needs therapy.
5)With severe myelo-dysfunction, renal dysfunction and/or liver dysfunction.
6)With other severe diseases
a)Interstitial pneumonitis, pulmonary fibrosis or severe emphysema
b)Renal dysfunction
c)Liver dysfunction
d)Intestinal paralysis, ileus
e)Jaundice
f)Uncontrolled DM
7)Serious illness or medical conditions as defined below,
a)Patients with a previous history of congestive heart failure
b)Unstable angina requiring medication
c)Patients with a previous history of transmural infarct
d)Uncontrolled hypertension
e)Severe heart valve diseases
f)Hi-risk uncontrolled arrhythmias
g)Patients with left ventricular ejection fraction in the baseline is less
than 50% on MUGA (Multi Gated Acquisition Scan) or echocardiography.
8)with HBs(+)
9)Patients whom administered Flucitosine or Athazanavil sulfate
10)Patients whom administered Fenitoin and/or Warfarin
11)General administration of steroids
12)Woman who are pregnant or expect to be pregnant or nursing female
13)Patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms
14)Patients whom doctor in chief decides not to register to this study due to other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashiro Goto |
Organization
Osaka Medical College Hospital
Division name
Cancer Chemotherapy Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL
072-683-1221
in2030@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Goto |
Organization
Osaka Medical College Hospital
Division name
Cancer Chemotherapy Cancter
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL
072-683-1221
Homepage URL
in2030@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪医科大学付属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 25 | 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
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
| 2011 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013867
