UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000448 |
|---|---|
| Receipt number | 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 10:42:40 |
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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
| Obstetrics 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
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/
s-take-imugo@zeus.eonet.ne.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000544
