UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Clinical Trial of Monotherapy with Irinotecan Hydrochloride (CPT-11) for Advanced or Recurrent Endometrial Cancer
Acronym	Irinotecan For Endometrial Cancer
Scientific Title	Phase II Clinical Trial of Monotherapy with Irinotecan Hydrochloride (CPT-11) for Advanced or Recurrent Endometrial Cancer
Scientific Title:Acronym	Irinotecan For Endometrial Cancer
Region	Japan

Condition
Condition	Advanced or recurrent endometrial cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of monotherapy with irinotecan hydrochloride (CPT-11) in patients with advanced or recurrent endometrial cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	PFS, safety, OS

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	Irinotecan hydrochloride
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	75 years-old >
Gender	Female
Key inclusion criteria	1. Patients with histologically confirmed (endometrial cytology or surgical histopathology) recurrence of endometrial cancer (excluding carcinosarcoma and sarcoma) 2. Patients with a history of up to 1 regimen of prior chemotherapy 1). At least 4 weeks have elapsed since the final date of treatment with the previous chemotherapy regimen, or there are no carry-over effects. 2). At least 4 weeks have elapsed since the final date of radiotherapy, or there are no carry-over effects. 3). At least 2 weeks have elapsed since the final dose of metabolic antagonists, hormone therapy, or immunotherapy, or there are no carry-over effects. 3.Patients aged from 20 years to younger than 75 years 4.Patients with a performance status (ECOG) of 0 to 1 5.Presence of measurable lesions (Compliance with RECIST: tumor diameter: 20 mm on CT scans or 10 mm on helical CT scans) 6.Patients for whom the results of previous imaging studies performed within 28 days before enrollment are available 7.Patients who are expected to survive for 3 months or longer 8.Patients with the following bone marrow, liver, and kidney functions based on data obtained within 1 week before enrollment 1)White-cell count: 3000/mm3< 2)Neutrophil count: 1500/mm3< 3)Platelet count: 100,000/mm3< 4)Hemoglobin level: 9.0 g/dL< 5)Total bilirubin level:<1.5 mg/dL 6)AST (GOT): <2.5 times the institutional upper limit of normal 7)ALT (GPT):<2.5 times the institutional upper limit of normal 8)Serum creatinine level: the institutional upper limit of normal 9.Patients from whom written informed consent to participate in the study has been directly obtained.
Key exclusion criteria	1. Patients with a history of treatment with topoisomerase I inhibitors (irinotecan, nogitecan, etc.) 2. Patients with liver dysfunction (jaundice) or serious renal dysfunction 3. Patients with serious drug allergies (hypersensitivity) 4. Patients with active double cancers 5. Patients who have or are suspected to have clinically problematic infections 6. Patients with poorly controlled hypertension or diabetes mellitus 7. Patients who have marked electrocardiographic abnormalities or clinically problematic cardiac disease 8. Patients with severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.) 9. Patients with a history of clinically problematic mental disorders, central nervous system disorders, or cerebrovascular/cranial nerve disease 10. Patients with fresh gastrointestinal bleeding, intestinal paralysis, intestinal obstruction, or peptic ulcer 11. Patients with pleural effusion, ascites, or pericardial effusion requiring removal with the use of a drain 12. Patients with brain metastasis or who are suspected to have brain metastasis on the basis of clinical symptoms 13. Patients with diarrhea (watery stool) 14. Patients who are receiving atazanavir sulfate 15. Patients who are continuously receiving systemic administration of steroids (oral or intravenous infusion) 16. Pregnant women, breast-feeding women, or women who may (want to) become pregnant 17. Patients who are considered ineligible for participation in the study by the physician responsible (partially responsible) for treatment
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Shin Middle name Last name Nishio
Organization	Kurume University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	830-0011
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7573
Email	shinshin@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Shin Middle name Last name Nishio
Organization	Kurume University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	830-0011
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7573
Homepage URL
Email	shinshin@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kurume University
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
Tel	0942-35-3311
Email	sangaku@kurume-u.ac.jp

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	2015 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	26
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	2015 Year 01 Month 01 Day
Date of IRB	2015 Year 03 Month 16 Day
Anticipated trial start date	2015 Year 04 Month 13 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 08 Day
Last modified on	2020 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019813