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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005525
Receipt No. R000006537
Scientific Title Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Date of disclosure of the study information 2011/05/01
Last modified on 2013/01/31

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Basic information
Public title Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Acronym Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Scientific Title Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Scientific Title:Acronym Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Region
Japan

Condition
Condition Patients with platinum-refractory and resistant ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the maximum tolerated dose (MTD) and the domestic recommended dose (RD) of pegylated liposomal doxorubicin in combination with irinotecan therapy in Patients with platinum-refractory and resistant ovarian cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The maximum tolerated dose of combination chemotherapy consisting of pegylated liposomal doxorubicin in combination with irinotecan
Key secondary outcomes

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 PLD (25-30mg/m2 ,day1)
CPT-11 (50-60mg/m2 , day 1,8)
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) Patients with a histologic diagnosis of epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer.
2) Age: 20 years old or older, and under 75 years old.
3) Patients 1st-line or 2nd-line chemotherapy of platinum is required. Platinum-based regimen and is defined as progressive disease within 12 months of completing the prior therapy.
4) Patients took 3 coourse or more Platinum-based chemotherapy as 1st- or 2nd-line chemotherapy.
5) ECOG Performance Status: 0-1.
6) Patients who have genetic polymorphism of UGT1A1
7) Reasonable organ function.
WBC: 3,000-12,000/mm3
ANC: >1,500/mm3
Hb: >10.0g/dL
Platelet: >75,000/mm3
AST,ALT: less than or equal to 2.5x institutional ULN
ALP: less than or equal to 2.5x institutional ULN
Bilirubin: less than or equal to institutional ULN
Serum creatinine: less than or equal to 1.5x institutional ULN
LVEF: 50% or more
ECG: within normal limits
8) Patients must have signed informed consent.
Key exclusion criteria 1) Patients with severe complications or active infection.
2) Patients with prior diagnosis of malignancy are not eligible. Exceptions are(non-melanoma skin cancer, and carcinoma in situ.-other malignancies curatively treated and > 5 years without evidence of recurrence)
3) Patients with massive pleural effusion and/or ascites.
4) Patients with massive pericardial fluid.
5) Patients with unstable angina or those who have had a myocardial infarction within the past 90 days.
6) Patients with brain metastasis who have symptoms or require administration of steroid or antihydropic.
7) Patients with bowel paralysis or obstruction.
8) Patients with diarrhea or watery stool.
9) Patients with apparent interstitial pneumonitis or pulmonary fibrosis
10) Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation.
11) Patients who have received prior chemotherapy consisting of pegylated liposomal doxorubicin.
12) Patients who have participated in other clinical trials.
13) Patients with history of hypersensitivity reactions to doxorubicin or irinotecan or the components of pegylated liposomal doxorubicin.
14) Patients who are pregnant, lactating, and have pregnant possibility or intention.
15) Patients who are decided to be ineligible for this trial by the investigators.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Tsujioka
Organization Fukuoka University, School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 45-1, 7-chome, Nanakuma, Jyounan-ku, Fukuoka city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Fukuoka University, School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address
TEL 092-801-1011
Homepage URL
Email

Sponsor
Institute Fukuoka University, School of Medicine
Institute
Department

Funding Source
Organization Fukuoka University, School of Medicine.
Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 05 Month 01 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
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
2010 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 28 Day
Last modified on
2013 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006537

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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