UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005952 |
|---|---|
| Receipt number | R000007035 |
| Scientific Title | Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for clear cell or mucinous ovarian cancer |
| Date of disclosure of the study information | 2011/07/08 |
| Last modified on | 2013/07/08 09:49:51 |
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Basic information
Public title
Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for clear cell or mucinous ovarian cancer
Acronym
Phase I-II study of Irinotecan and Gemcitabine for clear cell or mucinous ovarian cancer
Scientific Title
Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for clear cell or mucinous ovarian cancer
Scientific Title:Acronym
Phase I-II study of Irinotecan and Gemcitabine for clear cell or mucinous ovarian cancer
Region
| Japan |
Condition
Condition
Clear cell or mucinous ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective is to evaluate the feasibility of combination chemotherapy with Irinotecan and Gemcitabine for clear cell or mucinous ovarian cancer and to determine the recommended dose (Phase I). In Phase II study, the objective is to evaluate the response rate of this chemothearpy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Recommended Dose
Response Rate
Key secondary outcomes
Safety
Overall Survival
Progression Free Survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A combination chemotherapy with Irinotecan (80-100 mg/m2) and Gemcitabine (800-1000 mg/m2) is administered on days 1 and 8 every 3 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Clear cell or mucinous ovarian cancer whose diagnoses were confirmed by pathologically.
2)Patients who have measurable disease.
3)Patients who have no history of previous chemotherapy.
4)Patients who have not received radiotherapy.
5)Performance Status (ECOG):0-2
6)Patients who are 20 years old or older and younger than 75 years old.
7)Patients who are expected to survive at least 3 months.
8)Patients wh have adequate bone marrow, cardiac, respiratory, hepatic , and renalfunction .
9)Patients who have signed an approved informed consent.
10)Patients who's UGT1A1 genotypes were evaluated.
Key exclusion criteria
1)Patients who have a history of severe hypersensitivity to drug.
2)Patients with interstitial pneumonia.
3)Patients who have mmasive ascites and/or pleural effusion.
4)Patients who have severe infectious diseases.
5)Patients with other malignant disease.
6)Women at pregnant state or possibly pregnant women.
7)Patients with mental diseases.
8)Patients with symptomatic brain metastasis.
9)Patients with severe coronary disease.
10) Patients with uncontrollable diabetic disease.
11)Patients with watery diarrhea.
12)Patients with severe ileus.
13)Patients with intestinal bleeding.
14)Patients with positeve HBs antigen.
15)Patients with severe medical complications.
16)Patients with systematic edema.
17)Patients who are considered inappropriate for this study by the doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Yoshino |
Organization
Osaka university, faculty of medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3351
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Yoshino |
Organization
Osaka university, faculty of medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Osaka university, faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 07 | Month | 08 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 08 | Day |
Last modified on
| 2013 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007035
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