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Recruitment status Terminated
Unique ID issued by UMIN UMIN000003944
Receipt No. R000004745
Scientific Title A Phase II Trial of Liposomal Doxorubicin (PLD) + Carboplatin (CBDCA) as Treatment in Relapsed, Plutinum-sensitive Ovarian Cancer
Date of disclosure of the study information 2010/07/26
Last modified on 2012/01/23

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Basic information
Public title A Phase II Trial of Liposomal Doxorubicin (PLD) + Carboplatin (CBDCA) as Treatment in Relapsed, Plutinum-sensitive Ovarian Cancer
Acronym A Phase II Trial of Liposomal Doxorubicin (PLD) + Carboplatin (CBDCA) as Treatment in Relapsed, Plutinum- sensitive Ovarian Cancer
Scientific Title A Phase II Trial of Liposomal Doxorubicin (PLD) + Carboplatin (CBDCA) as Treatment in Relapsed, Plutinum-sensitive Ovarian Cancer
Scientific Title:Acronym A Phase II Trial of Liposomal Doxorubicin (PLD) + Carboplatin (CBDCA) as Treatment in Relapsed, Plutinum- sensitive Ovarian Cancer
Region
Japan

Condition
Condition Ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A purpose of this study is to evaluate the efficacy and safety of PLD (30mg/m2) and CBDCA (AUC5) administered intravenously every 4 weeks to patients with relapsed platinum-sensitive Mullerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) of using best overall response (response rate) as a primary endpoint.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Best overall response (Response rate)
Key secondary outcomes 1. The incidence and the degree of adverse events and adverse drug reactions, etc.
2. The median duration of response and the range, etc. in response cases (CR or PR)
3. The median time to response and the range, etc. in response cases (CR or PR)4. The median time to death and the range, etc. in response cases (CR or PR)

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 Administere PLD (30 mg/m2) and CBDCA (AUC5), intravenously.
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 diagnosis of Mullerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) established by a histologic examination.
2)Patients who received one or two platinum-based chemotherapy and patients who use PLD+CBDCA as second-line or third-line therapy.
3)Patients having a disease progression since 6 months (180 days when the next day of the final treatment with a platinum based chemotherapy is treated as the 1st day) after the last dosage day of platinum based chemotherapy.
4)Patients with measurable lesions meeting RECIST criteria.
5)Patients who are at least 20 years of age and younger than 75 years of age at the enrollment.
6)Patients with ECOG Performance Status (abbreviated as P.S., hereafter) 0-2.
7)Patients who have adequate major organ functions and fulfill all of the following criteria in order to evaluate the efficacy and safety of PLD.
Neutrophils (total neutrophil count):>=1,500/mm3
Hemoglobin:>=9.0g/dL
Platelet:>=100,000/ mm3
Serum GOT (AST), GPT (ALT):<=2.5 times the upper limit of institutional normal range
Serum ALP:<=2.5 times the upper limit of institutional normal range
Total bilirubin: > 1.2mg/dL
Serum creatinine:<=1.5 times the upper limit of institutional normal range
Cardiac function LVEF:>=50%
Electrocardiograph: Normal or clinical irrelevant change
8) Patients judged to have at least 3-month life expectancy.
9) Patients who give consent of their own will in writing after being given a sufficient explanation by the investigator (or subinvestigator) about the contents of the study using the prescribed informed consent form and other explanatory documents.

Key exclusion criteria 1)Pregnant women, nursing mothers, and those who may be or are willing to be pregnant.
2)Patients with active double cancer (synchronic double cancer and asynchronous double cancer with no more than 5-year disease-free period. However, basal cell carcinoma in the skin, squamous cell carcinoma, and carcinoma in situ judged to be cured by local treatment, or intra-mucosal cancer-equivalent lesion are not to be included in active double cancer).
3)Patients with a severe psychiatric disorder that is considered to interfere with the conduct of this study.
4)Patients with concomitant disease that may affect the conduct of the study and the evaluation of PLD (severe one, or active and systemic infection, etc.).
5)Patients who had myocardial infarction and angina attack within 90 days (if the previous day of the enrollment is the initial date of reckoning, up to 90 days before).
6)Uncontrolled or severe cardiovascular disease including myocardial infarction.
7)Patients who have received bone marrow transplantation or have a therapeutic history of massive chemotherapy + hematopoietic stem cell transplantation.
8)Patients receiving, as prior therapy, anthracycline treatment exceeding 250 mg/m2 as a total doxorubicin equivalent dose.
9)Patients with a poorly controlled restrictive or obstructive pulmonary disease.
10)Patients with symptomatic brain metastasis.
11)Patients who are already receiving treatment with PLD.
12)Patients with a history of severe hypersensitivity.
13)Patients with a past history of hypersensitivity to doxorubicin products and any ingredients of PLD (MPEG-DSPE, soybean hydrogenised phospholipids, cholesterol, ammonium sulfate, histidine, sucrose, hydrochloric acid, sodium hydrochloride).
14)Other patients judged ineligible as subjects for the clinical study by the investigator (or subinvestigator).
Target sample size 85

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Fujita
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka Suita Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masami Fujita
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka Suita Osaka
TEL
Homepage URL
Email

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2010 Year 07 Month 26 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 Terminated
Date of protocol fixation
2010 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2010 Year 07 Month 23 Day
Last modified on
2012 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004745

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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