UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of Paclitaxel+Trastuzumab therapy in 2nd line treatment for advanced or recurrent gastric cancer with HER2 positive.
Title of the study (Brief title)	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	Masashiro Goto
Organization	Osaka Medical College Hospital
Division name	Cancer Chemotherapy Center
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Email	in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person	Masahiro Goto
Organization	Osaka Medical College Hospital
Division name	Cancer Chemotherapy Cancter
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Homepage URL
Email	in2030@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013867