Unique ID issued by UMIN | C000000128 |
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Receipt number | R000000191 |
Scientific Title | A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer |
Date of disclosure of the study information | 2005/09/07 |
Last modified on | 2015/08/31 15:48:19 |
A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
Japan |
relapsed small cell lung cancer
Hematology and clinical oncology |
Malignancy
NO
To establish the toxicities and maximum tolerated dose (MTD) of topotecan with carboplatin, and to determine the recommended dose (RD) for relapsed small cell lung cancer (SCLC).
Safety,Efficacy
Phase I,II
to establish MTD and to determine the RD.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The treatment schedule included carboplatin, diluted with 500 ml of normal saline, given intravenously over 90 minutes on day 5, and topotecan with 100 ml of normal saline, given intravenously over 30 minutes before the administration of carboplatin infusion on days 1 to 5, every 3 weeks
20 | years-old | <= |
75 | years-old | > |
Male and Female
Patients with histologic or cytologic confirmation of SCLC who received one prior chemotherapy regimen were eligible.
The eligibility criteria were as follows; (1) measurable lesions; (2) age ≥ 20, <75; (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; (4) adequate organ function
The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion or ascites, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, cerebrovascular disease, uncontrollable diabetes mellitus, severe infection.
38
1st name | |
Middle name | |
Last name | Takayasu Kurata |
Hyogo Medical Center for Adults
Department of Medical Oncology
13-70, Kitaoji-cho, Akashi City, Hyogo, Japan, 673-8558
078-929-1151
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
Hyogo Medical Center for Adults
Department of Medical Oncology
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
NO
2005 | Year | 09 | Month | 07 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed?term=19325498
Completed
2002 | Year | 04 | Month | 20 | Day |
2002 | Year | 09 | Month | 01 | Day |
2005 | Year | 12 | Month | 01 | Day |
2007 | Year | 05 | Month | 01 | Day |
2007 | Year | 06 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 07 | Day |
2015 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000191
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