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

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 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


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

Value
https://center6.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