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 |
A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase I
DLT(dose limiting toxicity),MTD(maximum tolerated dose),RD(recommended dose)
Safety, Response
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
18
1st name | |
Middle name | |
Last name | Hirohisa Yoshizawa |
Niigata University Medical and Dental Hospital
Bioscience Medical Research Center
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
025-227-2517
hy0522@med.niigata-u.ac.jp
1st name | |
Middle name | |
Last name | Hirohisa Yoshizawa |
Niigata University Medical and Dental Hospital
Bioscience Medical Research Center
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
025-227-2517
hy0522@med.niigata-u.ac.jp
Niigata Lung Cancer Treatment Group
none
Self funding
NO
2008 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2008 | Year | 04 | Month | 09 | Day |
2008 | Year | 08 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2014 | Year | 07 | Month | 01 | Day |
2008 | Year | 08 | Month | 29 | Day |
2015 | Year | 05 | Month | 29 | Day |
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 |