UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006999 |
|---|---|
| Receipt number | R000008261 |
| Scientific Title | Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy) |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2012/01/01 11:00:00 |
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Basic information
Public title
Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)
Acronym
Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)
Scientific Title
Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)
Scientific Title:Acronym
Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)
Region
| Japan |
Condition
Condition
Patients with platinum refractory and resistant Mullerian carcinoma (ovarian cancer, fallopian tubal, primary peritoneal cancer)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In our previous study(UMIN000004449), we have evaluated good efficacy and safety of gemcitabine and irinotecan administered intravenously every 3 weeks to patients with platinum refractory and resistant ovarian cancer ( including fallopian tube, primary peritoneal cancer). The purpose of this study is to evaluate the tailored dose chemotherapy of gemcitabine and irinotecan administered intravenously every 3 weeks to patients with platinum-refractory and resistant Mullerian carcinoma compared with optimal dose chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Adverse event
Response Rate ( disease control rate)
Overall Survival
Tolerability
Patient QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were treated with irinotecan followed by gemcitabine on days 1 and 8 every 3 weeks. Irinotecan dose was fixed at 50 mg/ m2. In tailored dose chemotherapy arm gemcitabine dose was tailored to individualized maximum repeatable dose.
Interventions/Control_2
In optimal dose chemotherapy arm gemcitabine dose was tailored to maximum tolerated dose.
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Patients with a histological diagnosis of ovarian cancer (including fallopian tube, or primary peritoneal carcinoma)
2)Prior two regimens chemotherapy is required. Platinum-resistant disease is based on the most recent exposure to a platinum-based regimen and is defined as progressive disease within 6 months of completing the prior therapy.
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.
Key exclusion criteria
1)Patients who have a history of hypersensitivity to gemcitabine and irinotecan.
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.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Tate , M.D. |
Organization
Chiba University Hospital
Division name
Department of Gynecology
Zip code
Address
1-8-1 Inohana Chuo Chiba Japan
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Tate , M.D. |
Organization
Chiba University Hospital
Division name
Department of Gynecology
Zip code
Address
TEL
Homepage URL
state@faculty.chiba-u.jp
Sponsor or person
Institute
School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 01 | Day |
Last modified on
| 2012 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008261
