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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004449
Receipt No. R000005325
Scientific Title Phase I/II Trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Ovarian cancer.
Date of disclosure of the study information 2010/10/26
Last modified on 2010/10/26

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Basic information
Public title Phase I/II Trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Ovarian cancer.
Acronym Phase I/II Trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Ovarian cancer.
Scientific Title Phase I/II Trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Ovarian cancer.
Scientific Title:Acronym Phase I/II Trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Ovarian cancer.
Region
Japan

Condition
Condition Patients with platinum-refractory and –resistant ovarian cancer ( including fallopian tube, primary peritoneal cancer)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the 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) having previous 2a therapeutic history of platinum-based chemotherapy using time to progression as a primary endpoint.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Time to progression
Key secondary outcomes Adverse event
Response Rate ( disease control rate)
Overall Survival
Tolerability
Patient QOL

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 Patients were treated with irinotecan followed by gemcitabine on days 1 and 8 every 3 weeks. Irinotecan dose was fixed at 50 mg/ m2, and gemcitabine dose was tailored to individualized maximum repeatable dose.
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
25 years-old <=
Age-upper limit
75 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 75 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 25

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Tate , M.D.
Organization School of Medicine, Chiba University
Division name Department of Reproductive medicine
Zip code
Address 1-8-1 Inohana Chuo Chiba Japan
TEL 043-222-7171
Homepage URL
Email state@faculty.chiba-u.jp

Sponsor
Institute School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 10 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2008 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
2010 Year 10 Month 26 Day
Last modified on
2010 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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