UMIN-CTR Clinical Trial

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	Obsterics 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
Email

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
Email	s-take-kmc@zeus.eonet.ne.jp

Sponsor
Institute	Natinonal Hospital Organization Kobe Medical Center
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000171

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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