UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001338
Receipt No. R000001623
Scientific Title A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
Date of disclosure of the study information 2008/09/01
Last modified on 2015/05/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
Acronym A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
Scientific Title A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
Scientific Title:Acronym A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), recommended dose (RD) and safety, antitumor activity of Docetaxel-Gefitinib in patients with Gefitinib refractory Non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes DLT(dose limiting toxicity),MTD(maximum tolerated dose),RD(recommended dose)
Key secondary outcomes Safety, Response

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 Patients will receive an infusion of docetaxel(40-60mg/m2) starting within 4 days of registration, every 3 weeks. Patients also continue to receive daily gefitinib orally.
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 Eligibility criteria
1)histologically or cytologically
confirmed NSCLC
2) postoperative recurrence or refractory unresectable III / IV
(3)maximal effect was confirmed in PR or SD by RECIST criteria after Gefitinib administration, and progressed subsequently (continuing Gefitinib to registration).
(4)no severe adverse event of Gefitib (except temporary interruption).
(5)chemotherapy treatment history of the 1-2 regimen(except postoperative adjuvant chemotherapy).
(6)20 years or older.
(7)PS(ECOG) 0-1
(8)preserved major organ function
leukocyte count >=3,000/mL, neutrophil count >=1,500/mL, hemoglobin concentration >=8g/dL, platelet count >=100,000/mL), kidney (creatinine=< 1.5x upper limit), liver (AST and ALT=< 2.0x upper limit), total bilirubin =< 1.5x upper limit, and pulmonary (PaO2 >= 60 torr) functions.
(9)life expectancy more than 3 month
(10)written informed consent
Key exclusion criteria Patients were excluded if they had docetaxel treatment, any active concomitant malignancies,
symptomatic brain metastases, past history of severe allergic reactions to drugs,interstitial pneumonia identified by chest CT, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure,
uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural
effusion or ascites.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Email hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Homepage URL
Email hy0522@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2008 Year 09 Month 01 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
2008 Year 04 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 05 Month 01 Day
Date trial data considered complete
2014 Year 05 Month 01 Day
Date analysis concluded
2014 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 29 Day
Last modified on
2015 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.