Unique ID issued by UMIN | UMIN000015496 |
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Receipt number | R000017985 |
Scientific Title | Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer |
Date of disclosure of the study information | 2014/10/21 |
Last modified on | 2014/10/21 20:36:50 |
Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer
Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer
Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer
Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer
Japan |
Patients with hypersensitivity reaction to carboplatin (ovarian cancer, fallopian tubal cancer, primary peritneal cancer)
Obstetrics and Gynecology |
Malignancy
NO
We plan the tailored dose chemotherapy of paclitaxeal and cisplatin weekly administered intravenously every 3 weeks to patients with platinum sensitive ovarian cancer ( including fallopian tubal primary peritneal cancer) with the hypersensitivity reactions(HSR) to carboplatin. The purpose of this study is to evaluate HSR to cisplatin for platinum sensitive recurrent patients with HSR to carboplatin.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Hypersensitivity reactions to cisplatin
Adverse events
Progression free survival
response rate (disease control rate)
overall survival
tolerability
patients QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients were treated with paclitaxeal followed by cisplatin weekly. Paclitaxeal dose was fixed at 80mg/m2. Cisplatin dose was tailored to individualized maximum repeatable dose. Stating dose of cisplatin was 20mg/m2.
20 | years-old | <= |
79 | years-old | >= |
Female
1)Patients with a histological diagnosis of ovarian cancer (including fallopian tube, or primary peritoneal carcinoma)
2)Prior one regimens chemotherapy is required. Patients had hypersensitivity reactions to carboplatin.
3)Patients have at least one measurable disease.
4)No chemotherapy within 2 weeks prior to the registration
5)Patients who are 20 years old or older and younger than 79 years old at the enrollment
6)Performance status:ECOG 0-2
7)Adequate bone marrow, renal, and hepatic function
8)Patients who are expected to survive more than 3 months.
9)Patients who have signed an approved informed consent.
1)Patients who have a history of hypersensitivity to paclitaxeal.
2)Patients with active infection
3)Patients with severe complications (Heart disease, uncontrolleddiabetes, malignant hypertension, or bleeding tendency)
4)Patients with other cancer within the past 5 years
5)Patients with myocardial infarction within 6 months or angina attack.
6)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician.
30
1st name | |
Middle name | |
Last name | Shinichi Tate, M.D. |
Chiba university Hospital
Gynecology
1-8-1 Inohana Chu-o-Ku Chiba Japan
043-222-7171
state@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Shinichi Tate, M.D. |
Chiba university Hospital
Gynecology
1-8-1 Inohana Chu-o-Ku Chiba Japan
043-222-7171
state@faculty.chiba-u.jp
SchooMedicine, Chiba university
None
Self funding
NO
2014 | Year | 10 | Month | 21 | Day |
Unpublished
Open public recruiting
2011 | Year | 03 | Month | 05 | Day |
2011 | Year | 05 | Month | 08 | Day |
2014 | Year | 10 | Month | 21 | Day |
2014 | Year | 10 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017985
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