UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017079 |
|---|---|
| Receipt number | R000019813 |
| Scientific Title | Phase II Clinical Trial of Monotherapy with Irinotecan Hydrochloride (CPT-11) for Advanced or Recurrent Endometrial Cancer |
| Date of disclosure of the study information | 2015/04/13 |
| Last modified on | 2020/08/08 21:09:52 |
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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
| Obstetrics 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
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
shinshin@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019813
