Unique ID issued by UMIN | C000000113 |
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Receipt number | R000000166 |
Scientific Title | phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer. |
Date of disclosure of the study information | 2005/09/05 |
Last modified on | 2016/09/27 16:30:54 |
phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Japan |
extensive disease small-cell lung cancer
Hematology and clinical oncology |
Malignancy
NO
to evaluate the efficacy and safety of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Safety,Efficacy
Phase II
Primary endpoint: response rate. Secondary endpoints: overall survival, time to progression, and toxicity.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
single-arm phse II study. Patients receive irinotecan 60 mg/m2 intravenously on day 1 and 8 plus cisplatin 60 mg/m2 intravenously on day 1 every three weeks for three cycle, then amrubicin 40 mg/m2 intravenously on day 1 to 3 every three weeks for three cycle.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1) small-cell lung cancer; 2) extensive disease; 3) Eastern Cooperative Oncology Group performance status of 0 or 1; 4) age of 20 to 70 years; 5) no prior chemotherapy; 6) neither palliative radiation nor surgery within 14 days; 7) measurable lesions; 8) a life expectancy of at least two months; 9) adequate organ fanctions; and 10) written informed consent.
1) symptomatic brain metastases; 2) pleural or pericardial effusion requiring drainage; 3) interstitial pneumonitis or pulmonary fibrosis; 4) active infection; 5) watery diarrhea, paralysis of the intestine, or ileus; 6) active gastric or duodenal ulcer; 7) continuous administration of steroids or non-steroidal anti-inflammatory drugs; 8) uncontrolled diabetes mellitus or angina pectoris; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) pregnancy or lactation; and 12) unsuitable for entry to the study, decided by a medical oncologist.
45
1st name | |
Middle name | |
Last name | aoru Matsui (head), Masashi Kobayashi (secretariat) |
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Department of Thoracic Malignancy
3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan.
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
West Japan Oncology Group
WJOG datacenter
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
NO
2005 | Year | 09 | Month | 05 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed?term=20479694
Completed
2004 | Year | 06 | Month | 24 | Day |
2004 | Year | 09 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2005 | Year | 09 | Month | 05 | Day |
2016 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000166
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