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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000448
Receipt No. R000000544
Scientific Title A phase II study of Irinotecan (CPT-11) for Leiomyosarcoma of Uterus
Date of disclosure of the study information 2006/07/13
Last modified on 2010/12/28

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Basic information
Public title A phase II study of Irinotecan (CPT-11) for Leiomyosarcoma of Uterus
Acronym A phase II study of Irinotecan (CPT-11) for Leiomyosarcoma of Uterus
Scientific Title A phase II study of Irinotecan (CPT-11) for Leiomyosarcoma of Uterus
Scientific Title:Acronym A phase II study of Irinotecan (CPT-11) for Leiomyosarcoma of Uterus
Region
Japan

Condition
Condition Leiomyosarcoma of Uterus
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is conducted to assess the efficacy and the safty of irinotecan in patients with newly diagnosed or recurrent Leiomyosarcoma of Uterus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Tumor Response
Key secondary outcomes Progression- Free Survival,Time to Progression,Toxicity,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 Irinotecan 100 mg/m2 q 4 weeks day 1,8,15 2 courses or more
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) Pathologicaly confirmed Leiomyosarcoma of the uterus with apparent metastasis
2) Unable to completely remove the tumors for newly diagnosed or recurrent disease
3) 20 years-old<=age<75 years-old
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
5) Less than on regimen of prior chemotherapy that does not include CPT-11.
* Patients with prior radiotherapy is eligible.
* Patients must have at least 4 weeks since prior chemotherapy, BRM, radiotherapy
6) At least 1 uni-dimensional measurable lesion >= 20 mm by conventional CT or MRI OR >= 10 mm by helical CT scan
7) Adequate bone marrow, cardiac, pulmonry functions. Lab data must be within 7 days from the registration
- Absolute neutrophil count:>= 1,500/mm3
- Platelet count:>= 100,000/mm3
- Hemoglobin:>= 9.0g/dL
- AST/ALT:<100 IU/L
- Bilirubin:<1.5mg/dL
- Serum creatinine:< 1.5mg/dL
8) Reasonable expectation for more than 12 weeks of survival period.
9) Written informed consent
Key exclusion criteria 1) Patients with previous CPT-11 chemotherapy.
2) Patients with any history of serious drug reactions or hypersensitivity to CPT-11
3) Patients with massive pleural, cardiac effusion, and/or ascites
4) Patients with symptomatic brain metastasis
5) Patients with active infections
6) Patients with diarrhea (watery stool) five times or more in a day
7) Patients with unstable angina, history of cardiac infarction within 6 months, or arrhythmia that requires medical treatment
8) Patients with intestinal paralysis or illeus
9) Patients with interstitial pneumonia or pulmonary fibrosis
10) Patients with active concomitant malignancy.
* Patients with history of any other malignancy within 5 years are ineligible.
* Patients with carcinoma in situ or intramucosal malignancy that was curable with local therapy are eligible.
11) Patients with uncontrolled diabetes mellitus
12) Patients who are under the treatment with Atzanavir
13) Patients during pregnancy or breast-feeding, or unwilling to the use of contraception
14) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Takeuchi ,MD,Ph.D.
Organization Iwate Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 19-1 Uchimaru, Morioka-City, Iwate 020-8505 Japan
TEL 019-651-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Takeuchi ,MD,Ph.D.
Organization JGOG2042 Coordinating Office
Division name Department of Obstetrics and Gynecology, Iwate Medical University
Zip code
Address 19-1 Uchimaru, Morioka-City, Iwate 020-8505 Japan
TEL 019-651-5111
Homepage URL http://www.jgog.gr.jp/
Email s-take-imugo@zeus.eonet.ne.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 07 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
2010 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 07 Month 13 Day
Last modified on
2010 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000544

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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