UMIN-CTR Clinical Trial

Public title

Phase II clinical study of the combination chemotherapy regimen of topotecan plus oral etoposide for the treatment of recurrent ovarian cancer

Acronym

Topotecan plus oral etoposide in recurrent ovarian cancer

Scientific Title

Phase II clinical study of the combination chemotherapy regimen of topotecan plus oral etoposide for the treatment of recurrent ovarian cancer

Scientific Title:Acronym

Topotecan plus oral etoposide in recurrent ovarian cancer

Region

Japan

Condition

Resistant ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate safety and efficacy of iv topotecan and oral etoposide for patients with recurrent ovarian cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate, Safty

Key secondary outcomes

Disease control rate,Progression-free survival, Overall survival,

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

Topotecan 1.0mg/m2 iv, day1-5,etoposide 50mg/body, p.o., day 1-21, repeat every 28 days

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

20

years-old

<=

Age-upper limit

79

years-old

>

Gender

Female

Key inclusion criteria

1) Histologically or cytologically proven ovarian cancer.
2) Patient who has at lesion. (measurable or unmeasurable)
3) Disease progression at the platinum containing chemotherapy or until 6 months from the last chemotherapy and patients with recurrent after the Liposomal Doxorubicin single agent therapy.
4) More than 4 weeks after last chemotherapy.
5) Patients aged of 20 to 79 years.
6) ECOG performance status (PS): 0-2
7) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 4,000/mm3 or over and 12,000/mm3 or under.
Neutrophil counts, 2,000/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 8.0g/dL or over.
AST and ALT, 100 IU/L or less.
Serum bilirubin, 1.5mg/dL or less.
Serum creatinin, x1.5 of ULN or less.
8) Patients with 3 months of life expectancy.
9) Written informed consent from the patients.

Key exclusion criteria

1) Patients with severe infectious disease and/or serious complication.
2) Patients who have severe gastrointestinal injury and/or gastrointestinal bleeding.
3) Patients who have necessary ascites and/or pleural effusion of measures.
4) Patients with interstitial pneumonia.
5) Patients with ileus.
6) Patients with active brain metastases.
7) Patients with active double cancer.
8) Patients who carried out bone marrow transplantation.
9) Patients who have the past of serious hypersensitivity.
10) Patients who are pregnant or who are at risk of pregnancy, or those who desire to become pregnant during their participation.
11) Patients who have uncontrolled diabetes mellitus.
12) Patients who received topoisomerase I inhibitor and/or topoisomerase II inhibitor containing chemotherapy within 6 months.
13) Inappropriate patients for this study judged by the physicians.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Yoichi Kobayashi

Organization

Kyorin University, School of Medicine

Division name

Obstetrics and Gynecology

Zip code

Address

6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 JAPAN

TEL

0422-47-5511

Email

yoichi@ks.kyorin-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoichi Kobayashi

Organization

Kyorin University, School of Medicine

Division name

Obstetrics and Gynecology

Zip code

Address

6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 JAPAN

TEL

0422-47-5511

Homepage URL

Email

yoichi@ks.kyorin-u.ac.jp

Institute

Kyorin University, School of Medicine

Institute

Department

Personal name

Organization

Kyorin University

Organization

Division

Category of Funding Organization

Self funding

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

杏林大学医学部付属病院（東京都）

Date of disclosure of the study information

2012

Year

02

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

2011

Year

10

Month

20

Day

Date of IRB

Anticipated trial start date

2012

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

17

Day

Last modified on

2017

Year

02

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008107