Unique ID issued by UMIN | UMIN000001837 |
---|---|
Receipt number | R000002140 |
Scientific Title | A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503) |
Date of disclosure of the study information | 2009/04/01 |
Last modified on | 2014/12/04 17:56:52 |
A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
Japan |
platinum resistant and taxane pretreated ovarian cancer
Obstetrics and Gynecology |
Malignancy
NO
To evaluate safety and efficacy of oral etoposide and iv irinotecan for patients with platinum resistant and taxane pre-treated ovarian, tubal and peritoneal cancer
Safety,Efficacy
Exploratory
Phase II
response rate
adverse event, progression free survival, overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
etoposide 50mg/m2, p.o., day 1-21, irinotecan 70mg/m2 iv, day1, 15, repeat every 28 days, up to 6cycles
20 | years-old | <= |
75 | years-old | >= |
Female
1. Cytologically or histologically proven ovarian, tubal, ore peritoneal cancer
2. Platinum resistant disease
3. Taxne pretreated disease
4. Age: 20-75 years old
5. PS: 0-2
6. One of the followings, or both of them
i) patients have measurable lesion
ii) patients have asseable lesion with elevated CA125 (more than 70)
7. No prior treatment with irinotecan, topotecan, or etopocide
8. No prior radiation to abdomen
9. Oral intake without parental nutrition
10. One of the followings
i) no drainage to effusion, or ascites in last 28 days
ii) no effusion or ascites to be drainaged
11. One of the followings
i) no chemotherapy or surgery in last 28 days
ii) no hormonal or biologic therapy in last 14 days
12. Patients without sever organ dysfunction
13. Written informed concsent
1. Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years
2. Patients who cannot undergo treatment due to the past history of mental disorder or the central nerve disorder
3. Women during pregnancy or breast-feeding
4. Patients who have been treated with the systemic steroids medication
5. Patients with active infection
6. Patients with uncontrollable hypertension
7. Patients with uncontrollable diabetes
8. Patients with history of myocardial infarction, unstable angina, or heart failure within six months
9. Patients with bowel obstruction
60
1st name | |
Middle name | |
Last name | Ikuo Konishi |
Graduate school of medicine, Kyoto University
Division of Gynecology and Obstetrics
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto,606-8507,Japan
1st name | |
Middle name | |
Last name | Koji Matsumoto |
JCOG0503 Coordinating Office
Hyogo Cancer Center medical oncology division
13-70,Kitaouji-cho,Akashi,Hyogo 673-8558,Japan
078-929-1151
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group(JCOG)
Ministry of Health, Labour and Welfare
Japan
NO
北海道大学病院(北海道)
札幌医科大学(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
筑波大学臨床医学系(茨城県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
東京慈恵会医科大学附属柏病院(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
東京慈恵会医科大学附属病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
順天堂大学医学部(東京都)
NTT東日本関東病院(東京都)
北里大学医学部(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
信州大学医学部(長野県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪市立大学医学部附属病院(大阪府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪市立総合医療センター(大阪府)
近畿大学医学部堺病院(大阪府)
兵庫県立がんセンター(兵庫県)
鳥取大学医学部(鳥取県)
国立病院機構呉医療センター・中国がんセンター(広島県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
佐賀大学医学部(佐賀県)
熊本大学医学部(熊本県)
鹿児島市立病院(鹿児島県)
琉球大学医学部(沖縄県)
2009 | Year | 04 | Month | 01 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/25449313
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
Completed
2009 | Year | 01 | Month | 30 | Day |
2009 | Year | 04 | Month | 01 | Day |
2013 | Year | 01 | Month | 01 | Day |
2009 | Year | 04 | Month | 01 | Day |
2014 | Year | 12 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002140
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |