UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2008 Year 09 Month 08 Day
Date of IRB	2008 Year 09 Month 08 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2020 Year 08 Month 01 Day
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	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005325