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

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 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


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

Value
https://center6.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