Unique ID issued by UMIN | UMIN000038464 |
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Receipt number | R000043835 |
Scientific Title | Phase I/II study of docetaxel and S-1 in previously treated patients with advanced non-small cell lung cancer |
Date of disclosure of the study information | 2019/11/03 |
Last modified on | 2019/11/01 14:45:52 |
Phase I/II study of docetaxel and S-1 in previously treated patients with advanced non-small cell lung cancer
LOGIK0408
Phase I/II study of docetaxel and S-1 in previously treated patients with advanced non-small cell lung cancer
LOGIK0408
Japan |
previously treated patients with advanced non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
we conducted this phase I/II trial combining docetaxel and S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine, and potassium oxonate)to determine a recommended dose of docetaxel and a fixed dose of S-1 and to confirm the efficacy and safety of this regimen
Safety,Efficacy
To determine a recommended dose, ORR
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients were treated at 3-week intervals with docetaxel on day 1 plus 80 mg/m2 oral S-1 from days 1 to 14
20 | years-old | <= |
75 | years-old | >= |
Male and Female
a cytologically or histologically confirmed diagnosis of incurable previously treated non-small cell lung cancer
no previous use of docetaxel or uracil plus tegafur(UFT)
age between 20-75 years
performance status of <=1 on the Eastern Cooperative Oncology Group scale
an estimated life expectancy of >12 weeks
adequate bone marrow function
a measurable lesion according to the Response Evaluation Criteria in Solid Tumors guidelines version 1.0
provision of written informed consent
active infection, massive ascites or pleural effusion
symptomatic brain metastasis
uncontrollable diabetes mellitus
severe comorbidity such as heart disease or renal disease, interstitial pneumonia, watery diarrhea, active concomitant malignancy
pregnancy or lactation, or other medical problems severe enough to prevent compliance with the protocol
Both of the following conditions were necessary
an interval of at least 4 weeks after the end of final therapy and recovery from the previous treatment
39
1st name | Koichi |
Middle name | |
Last name | Takayama |
Kyoto Prefectural University of Medicine
Department of Pulmonary Medicine
6020841
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5513
uchino@koto.kpu-m.ac.jp
1st name | Junji |
Middle name | |
Last name | Uchino |
Kyoto Prefectural University of Medicine
Department of Pulmonary Medicine
6020841
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5513
uchino@koto.kpu-m.ac.jp
Clinical Research Support Center Kyushu
Clinical Research Support Center Kyushu
Self funding
Kyoto prefectural University of Medicine
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
075-251-5513
uchino@koto.kpu-m.ac.jp
NO
2019 | Year | 11 | Month | 03 | Day |
N/A
Published
N/A
39
The median period of follow-up was 8 months(range, 1~39 months).
The response to treatment was as follows: complete response, 0; partial response, 3; stable disease, 24; PD, 5; and no effect, 7.
2019 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 05 | Day |
A total of 39 patients (31 men, 8 women; median patient age, 64 years; age range, 46 to 75 years)
The median number of cycles administered per patient was 3(range, 1~9). The relative dose intensities were 97.7% for docetaxel and 85.7% for S-1, respectively.
Grade 3 or 4 leukocytopenia, neutropenia, thrombocytopenia, and anemia occurred in 17 (44%), 26 (67%), 0 (0%), and 0 (0%) patients, respectively.
The median period of follow-up was 8 months(range, 1~39 months).
The response to treatment was as follows: complete response, 0; partial response, 3; stable disease, 24; PD, 5; and no effect, 7.
Completed
2005 | Year | 05 | Month | 31 | Day |
2005 | Year | 05 | Month | 31 | Day |
2005 | Year | 05 | Month | 31 | Day |
2011 | Year | 03 | Month | 31 | Day |
2019 | Year | 11 | Month | 01 | Day |
2019 | Year | 11 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043835
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