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Recruitment status Completed
Unique ID issued by UMIN UMIN000006223
Receipt No. R000007370
Scientific Title Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer
Date of disclosure of the study information 2011/09/01
Last modified on 2016/08/23

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Basic information
Public title Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer
Acronym Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer(JFMC45-1102)
Scientific Title Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer
Scientific Title:Acronym Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer(JFMC45-1102)
Region
Japan

Condition
Condition HER2 positive advanced or recurrent gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of trastuzumab and paclitaxel combination therapy in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Best Overall Response Rate
Key secondary outcomes Progression Free Survival
Time to Treatment Failure
Overall Survival
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 : 8 mg/kg(i.v.) for the initial dosing and 6 mg/kg for subsequent administration.
Trastuzumab administration will be repeated every 3 weeks.

Paclitaxel : 80 mg/m2 administered weekly on days 1, 8, and, 15 of 4-week period.
(Paclitaxel administration will be continued with 3 weekly infusions and 1 week of rest.)
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)Histlogically confirmed Gastric adenocarcinoma
2) Age: 20 years or older
3) HER2 positive (IHC 3+ or IHC 2+ /FISH +)
4)Previous chemotherapy completed at least 14 days before.
5) received one or more prior chemotherapy for gastric carcinoma, does not include trastuzumab and taxanes.
6)History of chemotherapy must be contain 5-fluoropyrimidine
7) Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline.
8)Performance Status (ECOG scale) 0-2
9)Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of >= 50% required)
10) Adequate organ function as follows:
i) neutrophils >=1,500/mm3,
ii) platelets >=100,000/mm3,
iii) hemoglobin >=8.0g/dL,
iv) total bilirubin <=1.5mg/dL,
v) AST(GOT)/ALT(GPT) <=100IU/L,
in hepatic metastasis <=200IU/L,
vi) serum creatinine <2.0mg/dL or creatinine clearance >=30mL/min.
11)Written informed consent.
Key exclusion criteria 1) Active synchronous or metachronous malignancy carcinoma in situ.
2) Severe or uncontrolled medical conditions (e.g.; infection, pulmonary fibrosis, intestinal paralysis, ileus, uncontrolled diabetes mellitus, cirrhosis, myocardial infarction and unstable angina.)
3) Severe infection and inflammation.
4) Severe mental disorders.
5) Peripheral motor or sensory neuropathy of CTCAEver.4.0 Grade2 or more.
6) Cardiac effusion, pleural or peritoneal effusion requiring treatment.
7) Polyoxyethylene Castor Oil allergy.
8) Administration of disulfiram,cyanamide,carmofur and procarbazine hydrochloride.
9)Pregnant or lactating female at anytime during the study
10) Other patients who are not suitable t for this study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization Keio University, School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name Office
Zip code
Address 1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL 03-5627-7594
Homepage URL http://www.jfmc.or.jp/
Email jfmc-dc@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
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

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1002/ijc.30383
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 08 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 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 08 Month 24 Day
Last modified on
2016 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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