UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006223 |
|---|---|
| Receipt number | 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 11:52:11 |
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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
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/
jfmc-dc@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007370
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