UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000115 |
|---|---|
| Receipt number | R000000171 |
| Scientific Title | A phase I/II study of weekly intraperitoneal paclitaxel +monthly intravenous carboplatin for mullerian carcinoma (ovarian, tubal, and peritoneal carcinoma) |
| Date of disclosure of the study information | 2005/09/09 |
| Last modified on | 2013/02/12 22:39:14 |
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Basic information
Public title
A phase I/II study of weekly intraperitoneal paclitaxel +monthly intravenous carboplatin for mullerian carcinoma (ovarian, tubal, and peritoneal carcinoma)
Acronym
Weekly IP PAC+CBDCA for mullerian carcinoma
Scientific Title
A phase I/II study of weekly intraperitoneal paclitaxel +monthly intravenous carboplatin for mullerian carcinoma (ovarian, tubal, and peritoneal carcinoma)
Scientific Title:Acronym
Weekly IP PAC+CBDCA for mullerian carcinoma
Region
| Japan |
Condition
Condition
Gynecological Mullerian tumors, such as ovarian, tubal, and peritoneal cancers.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted a phase I/II study of combination regimen with weekly ip-Paclitaxel (PAC) and monthly intravenous carboplatin(Carbo) to define the recommended dose (RD) and toxicity profiles as well as usefullness.
Basic objectives2
Others
Basic objectives -Others
Assessment of pharmakokinetics and progression free survival time
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
definition of recommended dose and assessment of feasibility of the treatment
Key secondary outcomes
response (using CA125 according to Rustin's criteria, reduction of ascitic fluid), time to progression
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
| Maneuver |
Interventions/Control_1
An estimation of MTD/RD of intraperitoneal administration with paclitaxel weekly in Carboplatin/paclitaxel regimens for optimal debulked ovarian cancer.
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Histological diagnosed gynecological Mullerian cancers,such as ovarian, tubal, and peritoneal cancer stage over IC(IC-IV) or recurrent disease with pelvic disease (retention of ascitic fluid, para-aortic nodes recurrence) with optimal debulked surgery.
(2)Adequate organ function with; ANC>1,500/mm3, platelets>100,000/mm3,Hb>9.0g/dl, S-GOT,GPT< 2 times of normal range,T-bil<1.5mg/dl, S-Crn < 1.5mg/dl,or Creatinin Clearance (CCr) > 40ml/min. EKG:normal, without heart disease and severe arhythmia
(3)ECOG Performance Status 0-2
(4)Patients expected to survive at least 6 months
(5)Patients who will be gotten fully informed consent for the clinical study
Key exclusion criteria
(1)Whom not to be suitable for eligibility criateria
(2)Known severe hypersensitivityor having past illness of hypersensitivity to any drug
(3)pregnant,milk-feeding woman or who is
expected to be pregnant
(4)Who have too much pleural effusion or pericardial effsion.
(5)Known hypersensitivity to these drugs(paclitaxel, and/or carboplatin) or to agent containing polyoxiethilene cremophol such as cyclosporine injection
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Takeuchi |
Organization
Natinonal Hospital Organization Kobe Medical Center
Division name
Gynecologic Oncology
Zip code
Address
3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan
TEL
078-791-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Takeuchi |
Organization
Natinonal Hospital Organization Kobe Medical Center
Division name
Gynecologic Oncology
Zip code
Address
3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan
TEL
078-791-0111
Homepage URL
s-take-kmc@zeus.eonet.ne.jp
Sponsor or person
Institute
Natinonal Hospital Organization Kobe Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant of Ntional Cancer Center Hospital:Grant for cancer study 2002 from Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Medical College, Kobe University, Iwate Medical University, Tottori University
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
| 2005 | Year | 09 | Month | 09 | 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
Results
By now 12 patients were recruited, and all patients were completed. As for pharmacokinetics and adverse events the results were reported at 2004 ASCO procedings. At ECCO 12 meeting the presentation was made according to the results except for survival. The survivals and outcome would be reported soon.
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
| 2001 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 05 | Month | 01 | Day |
Other
Other related information
No treatments related death were observed. Unexpected adverse events have not observed.
Management information
Registered date
| 2005 | Year | 09 | Month | 05 | Day |
Last modified on
| 2013 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000171
