UMIN-CTR Clinical Trial

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

Patients with platinum-refractory and –resistant ovarian cancer ( including fallopian tube, primary peritoneal cancer)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Time to progression

Key secondary outcomes

Adverse event
Response Rate ( disease control rate)
Overall Survival
Tolerability
Patient QOL

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

School of Medicine, Chiba University

Institute

Department

Personal name

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

10

Month

26

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2010

Year

10

Month

26

Day

Last modified on

2022

Year

02

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005325