UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2)
Acronym	A phase II study of paclitaxel weekly administration for metastatic gastric cancer
Scientific Title	A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2)
Scientific Title:Acronym	A phase II study of paclitaxel weekly administration for metastatic gastric cancer
Region	Japan

Condition
Condition	Fluoropyrimidine failure metastatic gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of weekly 90 mg/m2 paclitaxel administration for fluoropyrimidine-resistant metastatic gastric cancer patients, and identify the possible biomarkers
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	1)Tumor response rate 2)Genotype-phenotype association (CYP3A4 and CYP2C8 vs toxicity), and expression-phenotype association (MDR1 and TUBB vs tumor response)
Key secondary outcomes	1)Adverse events, 2)Progression free-survival (PFS) 3)Overall survival (OS) 4)Genotype-phenotype association (CYP3A4 and CYP2C8 vs PK parameter) 5) Gene expression-phenotype association (MDR1 and TUBB vs PK parameter) 6) Possible pharmacogenomic factors other than CYP3A4, CYP2C8, MDR1, and TUBB

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	Intravenous administration of paclitaxel 90 mg/m2 on Days 1, 8, and 15, every 4 weeks
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)With pathologically proven gastric cancer (2)With advanced gastric cancer resistant to fluoropyrimidines (up to 1 prior regimen other than fluoropyrimidines-based therapy) (3)With at least one measurable lesion (RECIST) (4)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3, neutrophil count>=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level<=1.5 mg/dl, BUN<=25 mg/dl, serum creatinine level<=1.5 mg/dl, creatinine clearance>=50 ml/min., C-reactive protein <=1.0 mg/dl, normal ECG (5)ECOG performance status<=2 (6)Prior chemotherapy was completed>=28 days prior to entry (7)Life expectancy estimated>=12 weeks (8)Age 20-75 years (9)With collected tissue samples for pharmacogenomic analysis (10)With written informed consent
Key exclusion criteria	(1)With other serious disease: Ischemic heart disease, arrhythmia, Myocardiac infarction occurred within 6 month,Liver cirrhosis, Hemorrhage/bleeding>=grade3(NCI-CTC),Symptomatic psychological disease, Uncontrollable diabetes, Obstructive bowel disease (2)Active secondary cancer (3)A past history of drug allergy (4)A past history of allergic reaction to polyoxy-ethilen oil (5)Prior chemotherapy including a taxane (6)Peripheral neuropathy>=grade 2 in prior chemotherapy (7)Pregnancy or breast feeding (8)Ineligible decision by principal investigator (9)Active hepatitis or syphilis
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiko Nishiyama
Organization	Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name	Department of Translational Cancer Research
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5839
Email

Public contact
Name of contact person	1st name Middle name Last name Masahiko Nishiyama
Organization	Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name	Department of Translational Cancer Research
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5839
Homepage URL	http://www.hictdo.or.jp/tiken.html
Email	yamacho@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima Cancer Therapy Development Organization (HiCTDO)
Institute
Department

Funding Source
Organization	Hiroshima Cancer Therapy Development Organization (HiCTDO)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hiroshima Univ., Iwate Med. Univ.,Toyosu Hosp., Showa Univ., Kanagawa Cancer Ctr Hosp., Grad. Sch. Med., Hokkaido Univ., Kawakita Hosp., Grad. Sch. Med., Kobe Univ.
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	HiCTDO protocol #1
Org. issuing International ID_1	Hiroshima Cancer Therapy Development Organization (HiCTDO)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 10 Month 01 Day

Related information
URL releasing protocol	http://www.hictdo.or.jp/tiken.html
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Paper is being prepared (Sep. 1/2008)
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	2004 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2004 Year 04 Month 01 Day
Last follow-up date	2007 Year 12 Month 01 Day
Date of closure to data entry	2007 Year 12 Month 01 Day
Date trial data considered complete	2007 Year 12 Month 01 Day
Date analysis concluded	2008 Year 06 Month 01 Day

Other
Other related information	Step 1 (phase I) has been completed. (http://www.asco.org/ac/1,1003_12- 002636-00_18-0026-00_19-003091, 00.asp)

Management information
Registered date	2005 Year 09 Month 01 Day
Last modified on	2008 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000149

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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