UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001338
Receipt number 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 13:52:20

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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 or person

Institute

Niigata Lung Cancer Treatment Group

Institute

Department

Personal name



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

Value
https://center6.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