UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical study of the combination chemotherapy regimen of topotecan plus oral etoposide for the treatment of recurrent ovarian cancer
Title of the study (Brief title)	Topotecan plus oral etoposide in recurrent ovarian cancer
Region	Japan

Condition
Condition	Resistant ovarian cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Response rate, Safty
Key secondary outcomes	Disease control rate,Progression-free survival, Overall survival,

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	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

Eligibility
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

Research contact person
Name of lead principal investigator	Yoichi Kobayashi
Organization	Kyorin University, School of Medicine
Division name	Obstetrics and Gynecology
Address	6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 JAPAN
TEL	0422-47-5511
Email	yoichi@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Yoichi Kobayashi
Organization	Kyorin University, School of Medicine
Division name	Obstetrics and Gynecology
Address	6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 JAPAN
TEL	0422-47-5511
Homepage URL
Email	yoichi@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University, School of Medicine
Institute
Department

Funding Source
Organization	Kyorin University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	杏林大学医学部付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 17 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008107